Full Text
8016 GI/2025 (1)
REGD. No. D. L.-33004/99
The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 789] NEW DELHI, FRIDAY, NOVEMBER 28, 2025
CG-DL-E-04122025-268227
MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 28th November, 2025
G.S.R. 875(E).—In exercise of the powers conferred by sub-section (1) read with clauses (c), (f), (h), (i) and (s) of sub-section (1) of section 52 of the Legal Metrology Act 2009, (1 of 2010), the Central Government hereby makes the following rules further to amend the Legal Metrology (General) Rules, 2011, namely:—
1. (1) These rules may be called the Legal Metrology (General) Sixth Amendment Rules, 2025.
(2) They shall come into force on the 1st day of April, 2026.
2. In the Legal Metrology (General) Rules, 2011, in the Eight Schedule, after PART XII, the following PART shall be inserted, namely: —
‗PART XIII
EVIDENTIAL BREATH ANALYSER
Part 1
1. Scope.– (1) This specification applies to evidential breath analysers (hereinafter referred to as the ‗breath analysers‘) that are quantitative instruments, which provide a measurement result of alcohol concentration in exhaled human breath and are used for the purpose of establishing compliance, for fighting against alcohol abuse and for advancement of public safety.
(2) These instruments are ―evidential‖ and are the principal means by which a definitive breath alcohol measurement is obtained.
(3) For the purpose of this specification, the term ―alcohol‖ shall refer to ethyl alcohol or ethanol in a broader context, but, when dealing with test gas compositions, the exact chemical terminology for each substance shall be applied.
(4) Breath analysers shall be equipped with the following special features, namely: —
a) prohibit the displaying or reporting of results that do not represent the final measurement result;
b) mandating the inclusion of a printing device;
c) prohibiting operation of the analyser when no paper is detected in the printing device;
d) requiring further printed information in addition to the final measurement result; and
e) requiring final measurement results to be displayed and reported in terms other than the alcohol content in exhaled human breath (that is, physiological conditions such as percentage of blood or in terms of other quantities).
(5) This specification shall enumerate the minimum metrological specifications and tests applicable to model approval of quantitative breath analysers and give guidance for establishing metrological specifications for initial and re-verifications.
(6) The scope of this specification is limited to the types of breath analysers that use mouthpieces for sampling the breath.
2. Terminologies.—
A.– General metrology and legal metrology terms
(i) Adjustment of a measuring system: The set of operations carried out on a measuring system so that it provides respective indications corresponding to given values of a quantity to be measured.
(ii) Being in service (use): The operational life cycle of a measuring instrument after putting it in service, that is a measuring instrument in use, after repair, relocation or being rebuilt which shall be resold.
(iii) Calibration: The operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses that information to establish a relation for obtaining a measurement result from an indication.
(iv) Disturbance: The influence quantity having a value within the limits specified in this specification, but outside the specified rated operating conditions of the measuring instrument.
Note: An influence quantity is a disturbance if the rated operating conditions for that influence quantity are not specified.
(v) Experimental standard deviation: For a series of n measurements of the same measurand, the quantity s (qk) characterising the dispersion of the results and given by the following formula, namely:—
s (qk) = √[Σ(qk - q̄)² / (n-1)]
With qk being the result of the kth measurement and q̄ being the arithmetic mean of the n results considered.
(vi) Fault: The difference between the error of indication and the intrinsic error of a measuring instrument.
(vii) Fault limit: Value specified in this specification delimiting non-significant faults.
(viii) Intrinsic error: The error of a measuring instrument determined under reference conditions as specified in clause (i) of sub-paragraph (4) of paragraph 6 of Part 2 ;
(ix) Initial intrinsic error: The intrinsic error of a measuring instrument as determined prior to performance tests and durability evaluations.
(x) Mandatory periodic verification: The reverification of a measuring instrument, carried out periodically at specified intervals according to the procedure laid down.
(xi) Measurement error: The measured quantity value minus a reference quantity value.
(xii) Measurement precision: The closeness of agreement between indications or measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions.
(xiii) Measurement repeatability: The measurement precision under a set of repeatability conditions of measurement;
(xiv) Measurement reproducibility: The measurement precision under reproducibility conditions of measurement.
(xv) Putting into service (use): The moment of the first use by the end-user of a measuring instrument for the purposes for which it was designed.
(xvi) Repeatability condition of measurement: The condition of measurement, out of a set of conditions that includes the same measurement procedure, same operators, same measuring system, same operating conditions and same location and replicate measurements on the same or similar objects over a short period of time.
(xvii) Reproducibility condition of measurement: The condition of measurement, out of a set of conditions that includes different locations, operators, measuring systems and replicate measurements on the same or similar objects.
(xviii) Re verification: The verification of a measuring instrument after a previous verification.
(xix) Sensitivity: The quotient of the change in an indication of a measuring system and the corresponding change in a value of a quantity being measured.
Note 1: Sensitivity of a measuring system shall depend on the value of the quantity being measured.
Note 2: The change considered in a value of a quantity being measured must be large compared with the resolution.
Note 3: In the scope of this specification, sensitivity relates to the added substance which is not identical with the measurand.
(xx) Significant defect: The event that has an impact on the properties or functions of the measuring instrument or a fault.
(xxi) Significant fault: The fault exceeding the applicable fault limit.
(xxii) Stability of a measuring instrument: The property of a measuring instrument whereby its metrological properties remain constant in time.
(xxiii) Uncertainty of a measurement: The non–negative parameter characterising the dispersion of the quantity values being attributed to a measurand based on the information used.
(xxiv) Verification: The verification of a measuring instrument which has not been verified previously.
(xxv) Verification of a measuring instrument: The conformity assessment procedure which results in the affixing of a verification mark or issuing of a verification certificate, or both.
B. – Specific terms
(i) Anatomical dead space: The dead space in that portion of the respiratory system, which is external to the alveoli and includes the air- conveying ducts from the mouth to the terminal bronchioles.
(ii) Alveolar air: The air contained in the pulmonary alveoli where the gaseous exchange takes place between the blood and the gas contained within the alveoli.
(iii) Checking facility: The facility that is incorporated in a measuring instrument and enables significant defects to be detected and acted upon.
(iv) Drift: The continuous or incremental change over time in indication due to changes in metrological properties of a measuring instrument.
(v) End expiratory breath: The air considered sufficiently representative of alveolar air (as opposed to anatomical dead space).
(vi) Evidential breath alcohol analyser (hereinafter referred to as the ‗breath analyser‘): The instrument that measures and displays the breath alcohol mass concentration of exhaled human breath within specified error limits.
(vii) Measuring mode: The clearly indicated mode in which the breath analyser shall make measurements at the rate normally expected in service and in which it shall meet the performance requirements of this specification.
(viii) Memory effect: The effect on the true alcohol concentration of the sample caused by previous samples.
(ix) Metrological test mode: The mode in which the breath analyser is subject to metrological control such as verification or adjustment:
Note: In this mode, more information is available compared to the measuring mode (for example higher resolution, intermediate results, etc.), and access to maintenance and adjustment means is possible.
(x) Plateau of alcohol concentration: The time period during exhalation when the alcohol content is considered to reach a nearly stable value.
(xi) Portable evidential breath alcohol analyser (portable breath analyser): The evidential breath alcohol analyser intended for use in outdoor conditions (for example handheld devices generally powered by a battery).
Note: In the scope of this specification, portable breath analysers are designated as use case 3.
(xii) Standard measurement cycle: The measurement cycle of a breath analyser consists of all steps necessary to obtain a valid result from starting the measurement to sampling, analysing, internal control procedures, calculation and displaying of the result.
(xiii) Standby mode: The mode of the breath analyser whereby only certain circuits are energised in order to conserve power or prolong component life, or both, and to attain the measuring mode more rapidly than would be possible if starting from the switched-off state.
(xiv) Stationary evidential breath alcohol analyser (stationary breath analyser): The evidential breath alcohol analyser intended only for use in a fixed location within buildings or places providing stable environmental operating conditions.
Note: In the scope of this specification, stationary breath analysers are designated as use-case 1.
(xv) Transportable evidential breath alcohol analyser (transportable breath analyser): The easily transportable evidential breath alcohol analyser intended for use in mobile applications (for example in vehicles).
Note: In the scope of this specification, transportable breath analysers are designated as use-case 2.
C. – Software terms
(i) Authenticity: The result of the process of authentication (passed or failed).
(ii) Authentication: The checking of the declared or alleged identity of a user, process, or measuring instrument.
Note: This shall be necessary when checking that downloaded software originates from the owner of the certificate.
(iii) Cryptographic means: The means such as encryption or decryption with the purpose of hiding information from unauthorised persons, or hashes and signatures, to ensure integrity and authenticity.
(iv) Error log: The continuous data file containing an information record of failures or significant defects that have an influence on the metrological characteristics of the measuring instrument.
(v) Hash function: The function which maps values from a large domain into a smaller range.
(vi) Integrity (of programs, data, or parameters): The assurance that the programs, data, or parameters have not been subjected to any unauthorised or unintended changes while in use, transfer, storage, repair or maintenance.
(vii) Interface: The shared boundary between two functional units defined by various characteristics pertaining to the functions, physical interconnections, signal exchanges and other characteristics of the units.
(viii) Sealing: The means intended to protect the measuring instrument against any unauthorised modification, readjustment and removal of parts or software.
(ix) Software examination: The technical operation that consists of determining one or more characteristics of the software according to the specific procedure (for example, the analysis of technical documentation or running the program under controlled conditions).
(x) Software identification: The sequence of readable characters (for example, the version number and checksum) that represents the software or software module under consideration.
(xi) Transmission of measurement data: The electronic transportation of measurement data via communication lines or other means to a receiver, where they are further processed.
(xii) User interface: The interface that enables information to be interchanged between the operator and the measuring instrument, or its hardware components, or software modules.
Note: Examples are switches, keyboard, mouse, display, monitor, printer, touch—screen, software window on a screen including the software that generates it.
D.– Abbreviations, acronyms and symbols
AC - Alternating current
AM - Amplitude modulation
ASD - Acceleration spectral density
DC - Direct current
EBA - Evidential breath alcohol analyser
EM - Electromagnetic
e.m.f. - Electromotive force
ESD - Electrostatic discharge
EUT - Equipment under test
f nom - Nominal supply frequency
IEC - International Electrotechnical Committee
MPE - Maximum permissible error
mg/L - Milligram per litre
RF - Radio frequency
RH - Relative humidity
RMS - Root mean square
Tamb—low - Low ambient temperature
Tamb—high - High ambient temperature
TR - Reference temperature
Unom - Nominal supply voltage
Ubmin - Minimum battery supply voltage
UDC - Nominal DC voltage
β -Ethanol mass concentration in the gaseous phase
γ - Ethanol mass concentration in the liquid phase.
Note: The abbreviations for software validation procedures are specified in clauses (ii) and (iii) of sub-paragraph (3) of paragraph 6 of Part 2 of this specification.
3. Description of Instrument: (1) Schematic description:
(i) An EBA provides a means for sampling and then measuring the alcohol content of a sample of end expiratory breath of a human being.
(ii) The means for conveying the breath sample through the sampling system depends on the kind of alcohol sensor used in the specific EBA.
(iii) Incorporated into the sampling system is an alcohol sensor which analyses the breath sample and provides signals related to the concentration of alcohol.
(iv) The sensor signals are then electrically processed to display the results of a measurement in mg/L or another prescribed SI unit.
(v) Additionally, the EBA has a means to check whether the conditions for the acceptance of a breath sample are fulfilled.
(vi) The major components of an EBA include the following, namely:—
(a) replaceable mouthpieces to hygienically conduct the breath sample into the EBA for analysis;
(b) a hose to convey the breath sample through the sampling system or a sampling probe to convey a sub-sample of the breath sample through the sampling system;
(c) a display to monitor the flowrate, time and volume;
(d) sensor to measure the alcohol content of the breath sample;
(e) a data system to process the measurement signal including an indicating device to display the results and messages;
(f) an interface to an external data connection;
(g) a control facility to initiate and check instrument operations; and
(h) an adjustment facility to set the instrument operating parameters within prescribed limits.
(2) Sampling and mouthpiece:
(i) A specimen of an end expiratory breath sample from a continuous and uninterrupted expiration shall be analysed for alcohol concentration and the breath sample shall not be influenced by breathing techniques.
(ii) The EBA shall be capable of being used under satisfactory hygienic conditions and the use of individually packaged, replaceable mouthpieces for each measurement shall be indispensable.
(iii) The mouthpiece shall comply with the requirements of clause (ix) of sub-paragraph (1) of paragraph 2 of Part 2.
(3) Analysis: The EBA determines the alcohol concentration of the breath sample of end expiratory breath. Influences during the analysis caused by sampling or ambient conditions, or by both, shall be avoided.
(4) Presentation and storage of the result:
(i) On an EBA, the measurement results shall be presented on the display and secured for later access.
(ii) This shall be achieved by either printing or storing the result in the instrument memory, depending on the model, as well as, the requirements mentioned in sub-paragraph (9) of paragraph 1 of Part 2.
(5) Measurement cycle: A measurement cycle of an EBA consists of the following steps, namely:—
a) preparation for the measurement or getting ready for sampling;
b) sampling;
c) analysis of the sample including internal checking operations; and
d) presentation and storage of the result.
Note: A complete measurement cycle shall consist of one or more breath samples.
4. Units of measurement and decimal sign: (1) The EBA shall display or print or display and print measurement results in terms of mass concentration of alcohol in a specified volume of exhaled air.
(2) The EBA shall be able to indicate the mass concentration in milligram per litre of exhaled breath (mg/L) at least in the metrological test mode.
(3) The use of an equivalent unit of measurement is possible if the indication is in conformity with SI units.
(4) The decimal marker on the display or printout shall be either a comma or a dot on the line.
Part 2
1. Metrological Requirements.—
(1) Measuring range:
(i) The measuring range of the EBA shall be from 0.00 mg/L to at least 2.00 mg/L.
(ii) A higher upper limit of the measuring range shall be defined by the manufacturer.
(iii) The EBA shall indicate when its upper limit of measurement is exceeded with the mention of the value of the upper limit for example ―result > 2 mg/L‖.
(iv) The instrument shall fulfill the requirements of this specification for the complete specified measuring range.
(2) Masking of low results:
(i) A masking function shall be required which indicates 0.00 mg/L for measured mass concentrations equal to or less than a given value.
(ii) This masking function shall be deactivated in the metrological test mode.
(3) Scale interval:
(i) For the indication of the result, the scale interval shall be 0.01 mg/L in the measuring mode.
(ii) A measured value with three decimal places shall be truncated to two decimal places (for example a measured value of 0.427 mg/L is truncated to 0.42 mg/L).
(iii) In the metrological test mode, the EBA shall display the result with a scale interval equal to 0.001 mg/L and this scale interval shall be used for metrological tests.
(4) Multiple indicating devices:
All indications (displays, printout, stored data or transmitted data) of the measurement results shall show the same value.
(5) Durability of the EBA:
(i) The provisions in sub-paragraphs (6), (7), (8), (9), (10) and (11) shall be met durably for the EBA.
(ii) The EBA shall be designed to maintain stability of its metrological characteristics over a period of time which shall be at least till the verification period.
(6) Maximum permissible errors: The following maximum permissible error shall apply within the rated operating conditions (specified in sub-paragraph (10)).
a) Maximum permissible errors for type approval and initial verification:
(a) The maximum permissible error, positive or negative, shall be 0.020 mg/L or 5 % of the reference value of mass concentration of alcohol, depending on whichever is greater.
(b) If the upper limit of the measuring range is greater than 2.000 mg/L, the maximum permissible error shall be.—
β/2 – 0.9 mg/L for all mass concentrations of alcohol greater than 2.000 mg/L.
(c) The maximum permissible error as specified in the present sub-clause also apply to verification after repair or for mandatory periodic verification.
(ii) Maximum permissible errors for re-verification and for EBA in service:
(a) The maximum permissible error, positive or negative, shall be 0.030 mg/L or 7.5 % of the reference value of the mass concentration of alcohol, depending on whichever is the greater.
(b) If the upper limit of the measuring range is greater than 2.000 mg/L, the maximum permissible error shall be.—
3xβ/4 – 1.35 mg/L for all mass concentrations of alcohol greater than 2.000mg/L.
Table 1 - MPE for type approval, initial verification, re—verification and breath analysers in service.
| Serial | Reference values for alcohol | MPE of Paragraph | MPE of Paragraph | Comment |
| Number | concentration β | 1(6)(i) | 1(6)(ii) | |
|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) |
| 1 | 0.000 mg/L – 0.400 mg/L | 0.020 mg/L | 0.030 mg/L | |
| 2 | > 0.400 mg/L –2.000 mg/L | 5 % of β | 7.5 % of β | |
| 3 | > 2.000 mg/L | β/2 – 0.9 mg/L | 3xβ/4 – 1.35 mg/L | Only applicable for |
| | | | | enlarged measuring |
| | | | | range. |
(iii) Fault limit:
The fault limit shall be 0.020 mg/L.
(7) Repeatability:
(i) The repeatability of the instrument is expressed as the experimental standard deviation of a given number of measurement results.
(ii) The experimental standard deviation for all mass concentrations shall be less than or equal to one-third of the maximum permissible error.
(iii) The experimental standard deviation shall be calculated with the formula specified in clause (v) of sub-paragraph (1) of paragraph 2 of Part 1.
(8) Drift:
(i) Zero drift: Under reference conditions, the absolute value of zero drift shall not exceed 0.010 mg/L over a period of four hours.
(ii) Short-term drift: Under reference conditions, the absolute value of short—term drift determined at the measurement level of 0.40 mg/L shall not exceed 0.015 mg/L over a period of four hours.
(iii) Long-term drift: Under reference conditions, the absolute value of long—term drift determined every two weeks at the measurement level of 0.40 mg/L shall not exceed 0.020 mg/L in six months, using the same breath analysers.
(9) Memory effects:
(i) Memory effect with large differences in mass concentration: Under reference conditions the memory effect shall not exceed ± 0.010 mg/L.
(ii) Memory effect with small differences in mass concentration: Under reference conditions the memory effect shall not exceed ± 0.010 mg/L
(iii) Effect of water vapor (condensation): Breath analysers shall be designed and manufactured such that their errors do not exceed the maximum permissible error specified in clause (i) of sub-paragraph (6) when repeatedly tested with wet test gas at the respective low ambient temperature condition as specified in clause (i) of sub-paragraph (10).
(10) Operating conditions:
(i) Physical influence factors: Breath analysers shall be designed and manufactured such that their errors do not exceed the maximum permissible error specified in clause (i) of sub-paragraph (6) under the following rated operating conditions, namely:—
Table 2 — Minimum rated operating conditions.
| Serial | Condition | Temperature |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| (a) | Ambient temperature | Low (Tamb—low) | 0 °C for stationary breath analysers. |
| | | | –10 °C for transportable breath analysers. |
| | | | –10 °C for portable breath analysers. |
| | | High (Tamb—high) | 40 °C for stationary breath analysers. |
| | | | 45 °C for transportable breath analysers. |
| | | | 45 °C for portable breath analysers. |
| (b) | Ambient relative humidity | Up to 85 % at Tamb—high. |
| (c) | Atmospheric pressure | 860 hPa – 1060 hPa. |
| (d) | Random vibration | Stationary unit not expected to be subjected to vibration during routine use, therefore treated as a disturbance (see Table 4, clause e). |
| | | For transportable and portable breath analysers: |
| | | 10 Hz – 150 Hz, 7 m s—2 , 1 m2s—3 , –3 dB/octave. |
| (e) | DC mains voltage | As specified by the manufacturer. |
| (f) | AC mains voltage | Unom – 15 % to Unom + 10 %. |
| (g) | AC mains frequency | fnom – 2 % to fnom + 2 %. |
| (h) | Voltage of internal battery | All voltages between a new or freshly charged battery, down to the lowest voltage at which the instrument functions according to the specifications given by the manufacturer. |
| (i) | Voltage of a road vehicle battery | 12 V battery 9 V – 16 V. |
| | | 24 V battery 16 V – 32 V. |
| (j) | Mole fraction of hydrocarbons (as methane equivalent) in the environment Note: Methane equivalent: The content of hydrocarbons shall be expressed in ppmvol methane (CH4) equivalent. For the actual test, other hydrocarbons shall be | 0 µmol/mol to 5 µmol/mol. |
used and the necessary concentration of that hydrocarbon shall be recalculated by dividing 5 ppm by the number of carbon atoms in the molecule. Methane equivalent is a value at the minimum rated operating conditions.
(k) Mole concentration of carbon dioxide in the exhaled air | Up to 80 mmol/mol. |
Note: These provisions apply separately to each influence factor and to each error determination.
(ii) Conditions of exhalation: For a representative measurement, certain conditions of exhalation (for example continuity and flow) shall be fulfilled. The breath analysers shall provide an error message if one or more of the following conditions are not fulfilled and the conditions, specified by the manufacturer shall comply with the following values, namely:—
(I) exhaled volume: greater than or equal to 1.2 L;
(II) flowrate: greater than or equal to 0.1 L/s; and
(III) exhalation time: greater than or equal to 3 s.
(11) Disturbances and physiological influence substances:
(i) Disturbances:
(I) Breath analysers shall be so designed and manufactured to ensure that when they are exposed to the disturbances indicated below:—
(a) either significant faults do not occur; or
(b) significant faults are detected and acted upon by means of a checking facility.
(II) These provisions shall be applied separately to each individual cause of disturbance and each part of the measuring instrument. The choice of applicability of any of the provision is left to the manufacturer.
(III) Table 3 specifies the disturbing phenomena and their maximum level to which the breath analysers shall be immune while being exposed during its operation. ―Immunity‖ means that no significant fault will occur unless this fault is detected and acted upon.
Table 3 - Breath analysers shall be immune to the disturbances specified hereunder during exposure and in operation.
| Serial | Disturbance | Conditions |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| (a) | Radiofrequency (RF), electromagnetic fields | In the frequency range from 0.15 MHz to 6000 MHz |
| | | Field strength 10 V/m; 80 % AM sinusoidal modulated |
| (b) | Electrostatic discharges | Up to 6 kV contact discharge or 8 kV air discharge |
| (c) | Bursts on AC or DC mains supply lines | Amplitude 1 kV |
| | | Repetition rate 5 kHz |
| (d) | Surges on AC or DC mains supply | AC or DC mains |
| | | Line to line Line to ground |
| lines | 1 kV | 2 kV |
|---|---|---|
| (e) | Bursts on signal, data and control lines | Amplitude 1 kV Repetition rate 5 kHz |
| (f) | Ripple on DC mains electrical power port | Ripple Sinusoidal harmonics |
| | | Harmonic frequency 2, 3 or 6 times rectified origin frequency |
| | | Amplitude (Upeak—peak/UDC) 2 % |
| (g) | Mains supply voltage dips and short inter—ruptions and short variations | DC |
| | | Amplitude of the rated voltage Duration |
| | | Voltage dips 40 % 70 % 0.01 s and 1 s |
| | | Short interruptions 0 % 0.001 s and 1 s |
| | | Voltage variations 85 % 120 % 0.1 s and 10 s |
| | | AC |
| | | Amplitude of the rated voltage Duration |
| | | Voltage dips 0 % 70 % 0.5 and 1 cycle 25 cycles |
| | | Short interruptions 0 % 250 cycles |
| (h) | Surges on signal, data and control lines | Line to line Line to ground Shield to ground |
| | | Unsymmetrical lines 1 kV 2 kV |
| | | Symmetrical lines 2 kV |
| | | Shielded I/O lines 2 kV |
| (i) | Electrical transient conduction along supply lines from the on—board battery of a vehicle | Battery voltage supply Unom = 12 V Unom = 24 V |
| | | Pulse 2a 112 V 112 V |
| | | Pulse 2b 10 V +20 V |
| | | Pulse 3a –220 V –300 V |
| | | Pulse 3b 150 V 300 V |
| (j) | Electrical transient conduction via lines other than supply lines | Battery voltage supply Unom = 12 V Unom = 24 V |
| | | Pulse a –60 V –80 V |
| Pulse b | 40 V | 80 V |
Note: Mains supply shall mean electrical power supply directly from a mains (non—local) network and shall not include use of the electrical power from transportable or mobile sources such as vehicle batteries or generators. DC mains shall not mean the DC provided by the output port of the AC to DC adapter applied for supplying the electrical power to the EBA. In this case the adapter is considered part of the instrument and thus the requirements for AC mains apply.
(IV) Table 4 specifies the disturbance phenomena and their maximum level to which the breath analyers shall be exposed and testing for immunity shall occur after exposure.
Note: ―Immune‖ means that no significant fault will occur unless this fault is detected and acted upon.
Table 4 — Disturbances to which breath analysers shall be immune after exposure.
| Serial | Disturbance | Conditions |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| (a) | Mechanical shocks | Stationary breath analysers | Transportable breath analysers | Portable breath analysers |
| | Height of fall | 25 mm | 50 mm | 1 m |
| | Number of falls (on each bottom edge) | 1 | 1 | 6 |
| (b) | Shakes | 10 g, 6 ms, 2 Hz, in 3 axes, 1000 shakes for each axis |
| (c) | Damp heat, cyclic (condensing) | Stationary breath analysers | Transportable breath analysers | Portable breath analysers |
| | Temperature | Not applicable | 55 °C | 55 °C |
| | Duration | | 2 cycles | 4 cycles |
| (d) | Storage temperature | –25 °C, 6 hours |
| | | +70 °C, 6 hours |
| (e) | Vibration | For stationary breath analysers: 10 Hz – 150 Hz, 1.6 m s—2 , 0.05 m2s—3 , –3 dB/octave |
(ii) Physiological influence substances: Breath analysers shall be designed and manufactured to ensure that on their exposure to the physiological influence substances indicated below (quantities are given in clause (ix) sub-paragraph (5) of paragraph 6), the sensitivity shall be limited to the values given in the following Table.
Table 5 — Physiological influence substances.
| Serial Number | Interfering substance | Sensitivity |
|---|---|---|
| | | (Change (±) of indication in mg/L per vapour mass concentration applied in mg/L) |
| (1) | (2) | (3) |
| 1 | Acetone | 0.2 |
| 2 | Methanol | 1 |
| 3 | Isopropanol | 1 |
| 4 | Carbon monoxide | 0.5 |
Note: Director (Legal Metrology) shall decide additional substances to be tested.
(iii) Optional disturbances expected in specific environmental conditions: For breath analysers to be used in specific environmental conditions which are not completely covered by the environmental conditions as specified in sub-paragraph (10) or this sub-paragraph as additional performance criteria concerning the specific conditions.
The specific environmental conditions shall include the following, namely:—
a) sandy or dusty environmental conditions similar to the conditions in dusty warehouses, during production of concrete and dusty outdoor regions;
b) salt misty environmental conditions similar to those on board sea—going vessels; and
c) water and moist outdoor conditions including light or heavy rain or occasional splashes of water similar to those on board smaller boats.
Measures shall be taken to protect the breath analyers that become exposed to such more severe circumstances from becoming influenced or disturbed and to prevent any degradation of performance of the breath analysers. Breath analysers that are claimed to be able to operate as required under these more severe conditions shall be marked as such. Such breath analysers shall be so designed and manufactured that after exposure to one of the disturbances indicated above, either significant faults do not occur, or significant faults are detected and acted upon by means of a checking facility.
Table 6 specifies optional disturbing phenomena and their maximum level which the breath analysers shall be able to withstand.
Table 6 – Optional disturbance expected in specific environmental conditions.
| (a) | Sand and dust | Cyclic temperature variation between 30 °C and 65 °C, maintaining the following conditions, namely:— |
|---|---|---|
| | | (I) Relative humidity: less than 25 % |
| | | (II) Air velocity: 3 m/s |
| | | (III) Particle concentration: 5 g/m3 |
| | | (IV) Composition of the particles |
| (b) | Salt mist | Temperature of environment and salt solution: 35 °C Mass fraction of NaCl of the salt solution: (5 ± 1) % Relative humidity of the test atmosphere: > 85 % |
| | | Salt solution to be nebulised to such an amount that it will condense with a rate of (1 to 2) mL/ hour per surface of 80 cm2 |
| (c) | Water | Test level index 2 |
| | | Test condition According to the protection class |
2. Technical requirements.–The technical requirements for breath analysers are divided into the following two sections, namely:—
(1) basic technical requirements; and
(2) optional technical requirements.
All EBAs shall fulfil the basic requirements. The optional requirements shall only apply when an EBA is equipped with these extra functions or functionalities (for example a printer).
(1) Basic technical requirements:
(i) Presentation of the measurement result: (a) Indicating device:
(I) Results either displayed or printed shall be reliable, easy to read and unambiguous under normal conditions of use.
(II) All indications (displays, printout, stored data or transmitted data) of one measurement result shall show the same value.
(III) On displays, the result of the measurement shall be presented in digital format by means of aligned figures. The height of the figures on the display shall be equal or greater than –
(A) 5 mm for illuminated displays, and
(B) 10 mm in all other cases.
(IV) The unit of measurement or its symbol shall appear in close proximity to the result with characters at least 3mm high.
(V) The characters shall be easily readable in all ambient light conditions.
(VI) If the characters are not illuminated the display shall have an illumination device.
(VII) It shall not be possible to confuse a zero indication prior to the subject sample measurement, and a subject result.
(b) Availability of measurement results: (I) It shall be possible to retain the results in a readable or accessible form for at least fifteen minutes.
(II) If other measurements shall be performed during this period, the previous result shall be accessible without ambiguity.
(III) If this requirement shall only be met by printing the results, the absence of paper in the printer shall prevent further measurements from being made.
(c) Presentations when in metrological test mode:
When the breath analyser is in metrological test mode, the indications and printed information during this mode shall be clearly and unambiguously distinguishable from those during the measuring mode.
(ii) Protection against fraud: (A) A breath analyser shall have no characteristics likely to facilitate its fraudulent use, either by accidental or by deliberate means when using the instrument in the normal manner.
(B) The possibilities for unintentional misuse shall be considered in the construction (hardware and software) to reduce them to a minimum. The following aspects shall be taken into account, namely:—
a) access to the metrological test mode shall be restricted;
b) it shall be impossible to make any adjustments without breaking the sealing;
c) it shall be possible to make any adjustments via the software only in the metrological test mode.
An EBA and its software shall be designed and constructed to minimise the risk of unintentional, accidental, or intentional misuse.
(iii) Checking operations: When powered on, the EBA shall automatically check its correct operation (for example checksums, watchdogs). When any defect or an error signal is detected, the instrument shall display an error message and shall not allow any further measurement. The EBA shall check correct operation automatically before and after each measurement.
(iv) Warm—up time: Under reference conditions (clause (i) of sub-paragraph (4) of paragraph 6), the breath analysers used in different use-cases shall be capable of attaining the measuring mode after being switched on in a time not greater than the warm-up times specified in the following Table.
Table 7 – Warm-up times for different use-cases.
| Serial | Reference to definition | Description of evidential breath alcohol | Maximum warm—up time |
| Number | | analyser | |
|---|---|---|---|
| (1) | (2) | (3) | (4) |
| 1 | clause(xiv) of item B of paragraph 2 of Part 1 | Use-case 1: stationary EBA | 15 min |
| 2 | clause(xv) of item B of paragraph 2 of Part 1 | Use-case 2: transportable EBA | 15 min |
| 3 | clause(xi) of item B of paragraph 2 of Part 1 | Use-case 3: portable EBA | 5 min |
Breath analysers equipped with a standby mode shall be capable of returning to a measuring mode in five minutes from the standby mode.
(v) Availability for measurement: From the moment the EBA indicates that it is ready to receive an exhalation, it shall be available for at least one minute. The EBA shall indicate its readiness to start a measurement and shall not perform measurements until it is ready to do so. When after a specified period of time the instrument is no longer ready to perform measurements, it shall indicate this status.
(vi) Power supply duration of internal batteries: If a portable EBA is powered only by internal rechargeable or none—rechargeable batteries, it shall be able to perform at least fifty individual measurements at reference conditions followed by twenty individual measurements at –10 °C without requiring recharge or exchange of the batteries when used within the rated operating conditions.
(vii) Continuity of the exhalation: (I) The EBA shall monitor the continuity of exhalation and shall give an indication if the flow of exhaled air is interrupted between the beginning of the forced exhalation and the end of the sampling.
(II) An audible or visual signal shall be given to indicate the continuity of the exhalation.
(III) The exhalation shall be considered interrupted if the flow falls below the minimum value specified in clause (ii) of sub-paragraph (10) of paragraph 1 of Part 2.
(viii) Alcohol in the upper respiratory tract: (I) The EBA shall be equipped with a function which automatically detects whether the measurement result is affected by the presence of alcohol in the upper respiratory tract (also called residual mouth alcohol).
(II) The technical documentation shall clearly describe the method that is applied in the respective breath analyser.
Note: Examples of possible solutions are given in Annexure B, and the basic requirements for a corresponding test performance are described in sub-clause (b) of clause (vi) of sub- paragraph (5) of paragraph 6.
(ix) Mouthpieces: The EBA shall be equipped with mouthpieces for sampling. The following requirements shall apply for mouthpieces, namely:–
a) the use of a mouthpiece for sampling shall be mandatory (clear instructions on how to insert and use the mouthpiece shall be given in the manual);
b) it shall be possible to replace the mouthpiece easily;
c) it shall not be possible to inhale air from previous usages (air from the sampling system) of the EBA;
d) the back pressure of the EBA shall not exceed 25 hPa at a flowrate of 0.2 L/s, when measured at the inlet of the mouthpiece with the mouthpiece connected to the EBA;
e) the mouthpiece shall prevent droplets and particles from entering the sampling system of the EBA.
(x) Software: The whole software of the EBA shall conform to these requirements and if the software of the EBA is separated into parts, each part shall separately conform to the same.
(a) Software identification: (I) The software of the EBA shall be unambiguously identified with its version number and by the result of a hash function or by a checksum.
(II) The identification shall be inextricably linked to the software itself and shall be calculated, then presented or printed, on command or displayed during operation or at start—up.
(III) The software identification and all its parts shall be stated in the model approval certificate or the certificate of conformity.
(b) Correctness of algorithms and functions: The measurement result and any accompanying information shall be displayed, recorded or printed, or both, correctly. The measuring algorithms and operations of an EBA shall be functionally correct. It shall be possible to examine the algorithms and functions by means of an appropriate validation method (for example metrological tests, software tests or software examination).
(c) Protection of software against fraud:
For protection against fraudulent use, the following requirements shall be fulfilled, namely:–
(I) the software shall be secured against unauthorised modification, loading, or changes by swapping the memory device;
(II) in addition to mechanical sealing, technical means shall be necessary to secure breath analysers having an operating system or an option to load software;
(III) software protection comprises sealing by mechanical, electronic and/or cryptographic means or a combination thereof, making an unauthorised intervention impossible or evident;
(IV) only clearly documented functions shall be allowed to be activated through the user interface and shall not facilitate fraudulent use;
(V) for the type approval procedure, the manufacturer of the measuring instrument shall declare and document all program functions that shall be activated through the user interface and shall state about the completeness of the documentation of these functions;
(VI) no hidden functions shall exist;
(VII) parameters that fix the characteristics of the breath analyser shall be protected against modification; and
(VIII) if necessary for the purpose of verification, displaying or printing of the current parameter settings shall be possible.
(d) Detection of significant defects: (I) For significant defect detection, checking facilities shall be implemented into the EBA.
(II) The software shall be checked at least at instrument start-up or boot-up and if a change in software occurs, it shall be detected by the EBA.
(III) The EBA shall abort the current measurement and prevent the use of the EBA for further measurements.
(IV) A detected significant defect shall be registered in an error log.
(e) Interfaces: If the EBA is equipped with interfaces, the following requirements shall be fulfilled, namely:–
(I) the functions, parameters and measurement results shall not be inadmissibly influenced by commands received via interface;
(II) there shall be an unambiguous assignment of each command to all initiated functions or data changes in the software;
(III) only allowed and documented commands shall be permitted to activate functions through the interfaces.
(f) Maintenance and verification of breath analyser software: (I) Installation of software in an EBA in use shall be considered as –
(A) a modification of the EBA, when exchanging the software with another updated and approved version; or
(B) a repair of the EBA, when re-installing the same version.
(II) The software of an EBA shall not be modified or installed via any interface or by other means without breaking the sealing.
(III) After installation or modification of the software of the EBA, the instrument shall not be used until a verification of the EBA has been performed and the sealing has been renewed.
(g) Software documentation: In addition to the general documentation required in sub-paragraph (2) of paragraph 6 the manufacturer shall submit the following documentation, namely:–
(I) description of the software and the manner of fulfilling, including,–
(A) the list of software modules that perform the functions;
(B) the description of the software interfaces that perform the functions and of the commands and data flows via this interface:
(C) the source code which shall be made available to the laboratory if a raised risk level (Level B) is required;
(D) list of parameters to be protected and description of the means of protection;
(II) description of the system configuration and minimal required resources;
(III) description of the security means of the operating system (password, if applicable);
(IV) description of the software sealing method;
(V) overview of the system hardware, for example topology block diagram, type of computer or type of network and where a hardware component performs the functions responsible for measurement, it shall also be identified;
(VI) description of the accuracy of the algorithms (for example filtering of A/D conversion results, calculation of the result or rounding algorithms);
(VII) description of the user interface, menus and dialogues and commands that communicate through the interfaces shall be documented;
(VIII) description of the software identification including the description of all encryption means (if any) and instructions for obtaining the identification from an instrument in use;
(IX) list of commands of each hardware interface of the EBA;
(X) list of durability errors that are detected by the software and a description of the detecting algorithms;
(XI) description of the datasets stored or transmitted (if applicable);
(XII) if fault detection is realised in the software, a list of faults that are detected and a description of the detecting algorithm; and
(XIII) if an audit trail is realised in the software, a description on how to access the audit trail.
(2) Optional technical requirements: The EBA shall be fitted with one or more of the following options which shall be either prescribed or shall be a feature of the construction chosen by the manufacturer.
(i) Durable recording of measurement results:
(a) Printing device: The EBA shall be fitted with a printing device (internal or external) and if this device is used for enforcement, the following requirements shall apply, namely:–
(I) the minimum height for the figures on the printout shall be 2 mm;
(II) the printout shall contain the following information, namely:–
(A) instrument reference;
(B) date and time of measurement;
(C) measurement results and their units; and
(D) identification on the printout of the person subjected to test;
(III) the printed scale interval shall comply with the requirements defined in sub-paragraph (3) of paragraph 1;
(IV) the printing device shall be fitted with checking facilities which enable significant defects to be detected and acted upon. ―Act upon‖ means that a warning shall be given or that the instrument shall not provide any printout of the measurement result. The following shall be checked:
(A) presence of paper and ink (if applicable);
(B) the status of the printer and its readiness for operation;
(V) when the internal printing device is exposed to the disturbances mentioned in sub-paragraph (11) of paragraph 1, either significant faults do not occur, or significant faults are detected and acted upon by means of a checking facility;
(VI) the data transmission to external printing devices for enforcement purpose shall comply with the requirements of sub clause (b).
(b) Storage and transmission of data: The EBA shall store measurement data for further enforcement applications or transmit measurement data before they are used for enforcement purposes and in such cases, the following requirements shall apply.
(I) The measurement result stored or transmitted shall contain all the information necessary for future enforcement use.
(II) Measurement shall be stored or transmitted automatically when the measurement is completed. When the final measurement result derives from a calculation, the individual measurement results that are necessary for the calculation must be automatically stored or transmitted with the final result.
(III) The EBA shall have sufficient permanency to store the data until it is no longer required for enforcement purposes. Storage capacity shall be at least 1000 measurements. It is permitted to delete stored data, but this shall not be possible in normal use. Data shall be deleted in one of the following ways, namely:–
a) when the memory capacity is reached, data is deleted in the same order as the recording order;
b) deletion is carried out after a special manual operation that shall require specific access rights. A warning shall be given before data is deleted.
Note: Other regulators shall contain strict limitations for the deletion of stored measurement data, which shall be applicable.
(IV) The stored or transmitted data shall be protected by hardware or software means to guarantee the authenticity and integrity of data and also guarantee the correct information about the time of measurement.
Note: The authenticity and integrity of data shall be protected for example by generating an electronic signature for each data set.
(V) The software that displays or further processes these data shall check the time of measurement, authenticity and integrity of the data. If an irregularity is detected, the data shall be marked as unusable.
(VI) If data is transmitted from the EBA (secure environment) to an external environment, the risk level for the transmission and storage of data shall be required and raised risk levels shall require the application of cryptographic methods.
Note: It is appropriate to require a raised risk level when considering an open network.
(VII) The software that displays or further processes the transmitted data for enforcement purposes shall be secured and shall check the authenticity and integrity of the data.
(VIII) The measurement shall not be inadmissibly influenced by a transmission and the loss of measurement data shall be avoided by stopping the measurement process and this information shall be easily accessible for the user (for example in the manual, or marked on the instrument) and the EBA shall give an appropriate error message.
(ii) Redundancy: The manufacturer shall –
(I) define a measurement cycle with more than one breath sample; or
(II) provide redundant measuring sensors within an EBA.
The requirements specified in the following sub-clauses shall apply.
(a) Configuration of the measuring instrument: The following shall be required, namely:–
(I) two independent measuring systems; or
(II) two or more measurements for a standard measurement cycle, either consisting of repeated breath samples or a check with a test gas as part of the measurement cycle.
In such cases, the measuring instrument shall be configured with the following options, namely:–
(A) The EBA shall be equipped with two independent measuring systems for ethanol concentration and depending on the specified measurement cycle, shall either be used for measurements of the same breath sample or in combination with a two-measurement cycle. Each measuring system shall comply with the requirements concerning precision and accuracy. Any disturbance of one measuring system shall not have any effect on the other measuring system larger than the maximum permissible error.
(B) The EBA shall require the use of a certified reference gas to verify the good operation of the analytical system within a short period of time.
(C) The EBA shall be configured with a measurement cycle requiring more than one separate breath sample, for example a two—measurement cycle.
Note: General information about a two-measurement cycle with separate breath samples shall be found in Annexure B.
(b) Measurement results:
The results generated shall comply with the following requirements.
(I) As configuration with two independent measuring systems:
(A) Each measuring system shall fulfill the requirements of clause (i) sub-paragraph (6) of paragraph 1 of Part 2 for maximum permissible error independently.
(B) When applied within a two-measurement cycle with two independent breath samples, the difference between the interim result of the first breath sample and the interim result of the second breath sample shall be smaller than twice the MPE of clause (i) sub-paragraph (6) of paragraph 1 of Part 2 for the lower of both the interim results.
(II) As configuration with a measurement with certified reference gas:
The difference of the measured result of the reference sample compared to the certified concentration value of the reference gas shall be smaller than the maximum permissible error of the device for the certified concentration value of the reference gas.
(III) As configuration with multiple breath samples for a measurement cycle:
(A) The EBA shall compare the parameters and results of each breath sample of the measurement cycle. Director (Legal Metrology) shall define the limits for the allowed variation between the breath samples regarding concentration, volume and exhalation time
Note: When defining the limits of variation between consecutive breath samples, the natural variation of the breath sample from a person shall be taken into account. Differences in alcohol concentration greater than a specified limit might be interpreted as an indicator of invalid measuring conditions. Differences in exhalation time and/or volume greater than a specified limit might be taken as an indicator that the measuring conditions are not comparable.
(B) the number of breath samples to be measured and how the final result is determined out of the measurement result for each breath sample shall be prescribed by Director (Legal Metrology)
Note: Different approaches exist to calculate the final result of a measurement cycle. This might be the lowest measured value, the mean value, or another method.
(C) shall prescribe which details of the multiple measurements shall be given on the printout.
(D) If these multiple breath samples are also used for the detection of alcohol in the upper respiratory tracts, either the requirements of sub-paragraph (1) or sub-paragraph (3) of paragraph 2 of Annexure B shall apply.
3. Operating instructions: (1) Instruction manual:
An instruction manual for users shall be made available for each individual instrument.
The instruction manual shall be in the official language and easily understandable and shall include –
a) operating instructions, including instructions for the mouthpiece (for example hygienic aspects of use);
b) maximum and minimum storage temperatures;
c) rated operating conditions;
d) warm-up time after switching on the electrical power;
e) all other mechanical and electromagnetic environmental conditions;
f) mechanical and electromechanical environment classes; and
g) safety and security conditions.
(2) Additional instructions: The EBA shall conform to the standards for electrical safety as specified in this Part for compressed gases. Manufacturers shall stipulate in their operating procedures that the person subjected to the test shall not introduce anything in their mouth for at least fifteen minutes prior to the collection of a breath sample.
4. Inscriptions and sealing.— (1) Inscriptions: The EBA shall be marked with a tamper-evident label on a visible part of the instrument with the following information, namely:–
(i) mandatory on the label in all cases:
a) manufacturer‘s trademark or corporate name;
b) type designation or model number;
c) type or model approval mark;
d) serial number of the instrument;
e) year of manufacture;
f) details of the electrical power:
(I) in the case of mains power: the nominal mains voltage, frequency and power required;
(II) in the case of power by a road vehicle battery: the nominal battery voltage and power required;
(III) in the case of an internal removable battery: the type and nominal voltage of the battery;
(ii) mandatory either on the tamper-evident label, or in the instruction manual if the size of the EBA is not sufficient:
a) measuring range;
b) ambient temperature range.
Note: Software identification shall be displayed on demand through the indicating device
(2) Sealing: Effective sealing devices shall be provided by the manufacturer on all parts of the breath analyser that are not materially protected in another way against operations liable to affect its accuracy or integrity and applies to –
(i) adjustment means;
(ii) replacement of specific parts, if this replacement is expected to change the metrological characteristics; and
(iii) software integrity.
5. Metrological Controls.– (1) Legal metrological control consists of the whole of legal metrology activities including type evaluation initial, and re-verification.
(2) Every test is subject to uncertainty and the uncertainty of the test method shall be taken into account in the decision on the applicability of the test method.
6. Pattern evaluation.— (1) Instruments submitted for type evaluation:
(i) Type evaluation shall be carried out on at least one instrument, which represents the definitive type.
(ii) The evaluation shall consist of the examination and tests specified in sub-paragraphs (2) to (5) of paragraph 6 and if applicable, the tests specifiedin sub-paragraph (6) thereof also.
(iii) The applicant shall supply at least one production sample of the instrument for type testing.
(iv) In order to accelerate the test procedure, the testing laboratory shall carry out different tests simultaneously on two instruments and in such case, the testing laboratory shall ensure that all submitted instruments are in conformance to type.
(v) All accuracy and influence tests shall be performed on the same instrument, butdisturbance tests shall be carried out on one or two additional instruments, whichshall also be submitted beforehand for the accuracy tests.
(vi) If a unit does not pass a specific test and as a result has to be modified or repaired, the applicant shall carry out this modification to all instruments supplied for testing.
(vii) If the testing laboratory has sound reasons to conclude that the modification shall have a negative influence on tests that already had a positive result, these testsshall be repeated.
(2) Documentation:
(I) The documentation submitted with the application for type approval shall include the following, namely:–
c) a description of its general principle of measurement;
d) a list of the essential sub-assemblies, components with their essential characteristics;
e) mechanical drawings;
f) electric or electronic diagrams;
g) installation requirements;
h) security sealing plan;
i) panel layout;
j) test outputs, their use and their relationships to the parameters being measured;
k) operating instructions that shall be provided to the user;
l) documents or other evidence that support the assumption that the design and characteristics of the measuring instrument comply with the requirements of this specification; and
m) a print sample, if applicable.
(II) If the EBA is equipped with a printing device, the manufacturer shall provide information about the quality of the printing paper to fulfil the requirements of readability.
(III) If the testing laboratory deems it necessary, it shall require more detailed documentation, either to be able to study the quality of the instrument, or to be able to document in sufficient detail the approved type, or both.
(3) Examination and tests: Examination and testing of instruments are intended to verify their compliance with the requirements of paragraphs 1 to 4 of Part 1 and paragraphs 1 to 4 of this Part. The examination and tests shall cover all the applicable requirements of paragraphs 3 and 4 of Part 1 and paragraphs 1 to 4 of this part.
(i) Visual examination: The instrument shall be given a visual inspection to obtain a general appraisal of its design and construction and the documentation shall be studied and in particular, the following aspects shall be examined, namely:–
a) units and decimal sign;
b) measuring ranges;
c) scale intervals;
d) presentation of the result;
e) protection against fraud;
f) checking operations;
(g) software;
(h) inscriptions and sealing;
(i) operating instructions;
(j) suitability for testing;and
(k) if applicable,–
(I) printing device;
(II) storage of measurement results; and
(III)Transmission of data.
(ii) Software validation: The validation procedure of the software related functionalities of Breath analysers is given in the following.
Table 1 - Software validation procedures.
| Serial | Chapter | Validation | Examination | Comments |
| Number | | Procedure | level | |
|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) |
| 1. | Software identification | AD + VFTSw | A | If high conformity (level B) is required, alsoperform CIWT. |
| 2. | Correctness of algorithmsand functions | AD + VFTSw | A | If high conformity (level B) is required, also perform CIWT/ SMT. |
| 3. | Prevention of misuse | AD + VFTSw | A | Only a low risk of misuse is assumed. |
| 4. | Fraud protection | AD + VFTSw | A | Only a low risk of fraud is assumed. |
| 5. | Defect detection | AD + VFTSw | A | |
| 6. | Interfaces | AD + VFTSw | A | |
| 7. | Maintenance of software | AD+VFTSw+ VFTM | A | For verified update procedures. |
| 8. | Storage of data | AD + VFTSw | A | For storage of data only with the EBA. |
| 9. | | AD + VFTSw + CIWT/SMT | B | If required for storage inunsecure storages. |
| 10. | Automatic storing | AD + VFTSw | A | If high conformity (level B) is required,also perform SMT. |
| 11. | Transmission of data | AD + VFTSw + CIWT/SMT | B | Transmission into open systems, if required |
Note1: The SMT validation procedure will be applied only in exceptional cases when the functions of a software module shall not be examined exclusively on the basis of written information (validation procedure CIWT). It is appropriate and effective in the verification of dynamic measurement algorithms.
Note2: The abbreviations for software validation are specified in Table 2.
Table 2 - Abbreviations for software validation.
| Serial | Abbreviation | Description | Application | Used for |
| Number | | | | examination |
| | | | | level: |
|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) |
| 1. | AD | Analysis of the documentation and validation of the design | Always | A |
| | | | | (normal level) |
| 2. | VFTM | Validation by functionaltesting of metrological functions | Correctness of the algorithms, uncertainty,compensating and correcting algorithms | |
| 3. | VFTSw | Validation by functionaltesting of software functions | Correct functioning of communication, indication,fraud protection, protection against operating | |
| | | | errors, protection of parameters, fault detection | |
| 4. | CIWT | Code inspection and walkthrough | All purposes | B |
| | | | | (raised level) |
| 5. | SMT | Software module testing | All purposes when input and output shall clearly be Specified. | |
Note: For detailed information about validation procedures and examination levels the international standard D 31 of International Organization of Legal Metrology shall be referred.
(iii) Operational tests: The instrument shall be submitted to the performance tests specified in sub-paragraph (5) of paragraph 6 to determine its correct functioningunder various conditions and influence factors.
(4) Test conditions and test gas generator:
(i) Reference conditions: Unless otherwise specified in the test conditions, the following Table outlines the ambient conditions that shallbe maintained during the testing.
Table 3 – Reference conditions
| Serial | Condition | Range of nominal value | Maximum variation during |
| Number | | | each test |
|---|---|---|---|
| (1) | (2) | (3) | (4) |
| 1. | Ambient temperature: | 23 °C ± 5 °C | 5°C in total with a drift of less |
| | | | than 3°C per hour |
| 2. | Ambient relative humidity: | 50 % ± 30 % | 10 % |
| 3. | Ambient pressure: | 860 hPa to 1060 hPa | 20 hPa (not applicable to long |
| | | | term drift tests) |
| 4. | Concentration of hydrocarbonsin the environment | 0 µmol/mol to 5 µmol/mol total volume fraction (as methane equivalent) | |
| 5. | AC mains voltage and frequency (if appropriate) | Nominal values specified in Table 2 of clause (i) of sub-paragraph (10) of paragraph 1. | Within the nominal values specified in Table 2 of clause (i) of sub-paragraph (10) of paragraph 1. |
Note: Throughout this specification ―reference conditions‖ refers to ambient conditions.
(ii) Characteristics of human breath: Human breath containing alcohol shall be considered as corresponding to the following characteristics, namely:–
(a) evolution of the flowrate curve during the breath exhalation: increasing and decreasing flow rates during exhalation;
(b) evolution of the alcohol concentration during the breath exhalation: increasing alcohol concentration during forced exhalation in an breath analyser to a characteristic plateau which represents the mass concentration in the end—expiratory breath;
(c) breath temperature of 34 °C;
(d) relative humidity of 95 %; and
(e) volume fraction of CO2 : up to 50 mmol/mol.
(iii) Test gas generator: The test gas generator shall be able to deliver a test gas with the target value of the mass concentration with an uncertainty less than or equal to one third of the maximum permissible error. Taking into account the duty cycle of the test gas generator, the tests shall be conducted with the maximum frequency permitted by the breath analyser.
(a) Characteristics of test gas: Unless otherwise specified, the test gas injected without interruption into the breath analyser shall be characterised by the parametric values given in the following Table. Regarding the humidity and CO2 content, the exceptions specified in Table 6 shall be considered at the respective tests.
Table 4 — Reference gas conditions.
| Serial | Parameter | Nominal value with allowed deviation |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Delivered volume | 2 L ± 0.3 L |
| 2. | Total duration of the injection (into the EBA) | Greater than or equal to 5 s |
| 3. | Type of profile | Constant flowrate |
| 4. | Ethanol concentration | According to the respective test (0.4 mg/L if not otherwise specified) with a deviation from the target value of ± (2/3 maximum permissible error) |
| 5. | Gas temperature | 34 °C ± 0.5 °C |
| 6. | Relative humidity of the gas | 95 % ± 5 % (without condensation) |
| 7. | Carrier gas | Air containing insignificant concentrations of impurities with a mole fraction of CO2 of: (50 ± 5 ) mmol/mol |
(b) Capabilities of test gas generator: (I) For the different tests, the test gas generator shall be of one of the two following types, namely:–
(A) type 1: the test gas generator delivers test gases with constant mass concentrations of alcohol;
(B) type 2: the test gas generator delivers a test gas which fulfils the breath profile specified in clause (ii) of sub-paragraph (4) of paragraph 6.
Note: For the complete testprogram, both types are needed.
(II) Table 5 classifies the features of the different test gas generators and simplified means stated in this specification.
(III) In the following clauses, compressed dry gases shall also be covered by the term ―test gas generator‖.
(IV) Table 5 is not intended to exclude the enhancement of advanced generator types with more features than currently marked or shown. The development of new combinations of features shall not be hampered with this table.
(V) Test reports shall indicate which generator and, if applicable the applied enhancements for this generator, was used for each test.
Table 5 — Generator types and features.
| Serial | Feature | Type 2 | Type 1 | Simplified | Simplified means – |
| Number | | generator | generator | means—type 1 | dry gas |
| | | | | without CO2 | with | without |
| | | | | | CO2 | CO2 |
|---|---|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
| 1. | Capability to generate profiles defined in sub-paragraph (2) of paragraph 4 | Applicable | - | - | - | - |
| 2. | Gas temperature: 34 °C ± 0.5 °C | Applicable | Applicable | Applicable | - | - |
| 3. | Relative humidity range: 95 % ± 5 % | Applicable | Applicable | Applicable | - | - |
| 4. | Mole fraction CO2 :(50 ± 5) mmol/mol | Applicable | Applicable | - | Applicable | - |
| 5. | Realisation of different flow rates | Applicable | Applicable | Applicable | Applicable | Applicable |
Note: For certain tests, the testing procedures shall specify the use of one of the specific types indicatedabove.
(VI) Annexure A provides information about the reference principles to be used and examples for test gas generators.
(VII) To test the capability of the EBA to make measurements on the end expiratory breath, the test gas generator used by the laboratory shall be capable of delivering test samples with the specification of sub-clause (a) of clause (iii), but with flowrate and alcohol profiles described in sub-paragraph (2) of paragraph 4 of Annexure A. Test gas generators with the feature of generating flow and alcohol profiles are described here as a type 2 gas generator.
(VIII) (A) For the complete test program, the type 2 generator shall be sufficient but for certain tests the use of test gases deriving from a type 1 generator (constant alcohol concentration) is allowed, or even by more simplified means (dry gases in cylinders).
(B) Such means shall consist in the use of dry or wet gases generated by simple test means (for example the absence of CO2 in test gases, constant mass concentration during injection).
(C) Table 6 shows an overview in which simplified test gases are allowed to be used for each test.
(IX) The test report shall indicate for each test the kind of test means used and the test gas parameters applied and shall also indicate the details of use of other gases and manner of establishing their equivalence with thereference gases.
Table 6 - Overview: use of simplified means.
| Serial | Test clause | Dry gases | Gases | Remarks |
| Number | | allowed | without CO2 | |
| | | | allowed | |
|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) |
| 1. | Sub-clause (a) of clause (v) of sub-paragraph (5) | Maximum permissible errors and repeatability | - | - | |
| 2. | Sub-clause (b) of clause (v) of sub-paragraph (5) | Drift | - | - | The humidity in breath might also cause a drift. Therefore, only wet test gases shall be used here |
| 3. | Sub-clause (c) of clause (v) of sub-paragraph (5) | Memory effects | - | - | |
| 4. | Sub-clause (d) of clause (v) of sub-paragraph (5) | Effect of water vapour (condensation) | - | Applicable | |
| 5. | Sub-clause (a) of clause (vi) sub paragraph (5) | Variations of the test gas parameters | Applicable | Applicable | Dry gases are allowed provided that the parameters of the test gas (flow, alcohol concentration profiles) shall be modified accordingly. |
| 6. | Sub-clause (b) of clause (vi) of sub-paragraph (5) | Alcohol in the upper respiratory tract | - | Applicable | |
| 7. | Sub-clause (a) of clause (vii) of sub-paragraph (5) | Temperature test (dry heat and cold) | - | Applicable | |
| 8. | Sub-clause (b) of clause (vii) of sub-paragraph (5) | Damp heat, steady state (non—condensing) | - | Applicable | |
| 9. | Sub-clause (c) of clause (vii) of sub-paragraph (5) | Static atmospheric pressure | Applicable | Applicable | (i) Dry gases or gases without CO2 are allowed in combination with a preliminary repeatability test performed with wet gases. |
| 10. | Sub-clause (d) of clause (vii) of sub-paragraph (5) | Random vibration | Applicable | Applicable | |
| 11. | Sub-clause (e) of clause (vii) of sub-paragraph (5) | DC mains voltage variations | Applicable | Applicable | |
| 12. | Sub-clause (f) of clause (vii) of sub-paragraph (5) | AC mains voltage variations | Applicable | Applicable | |
| 13. | Sub-clause (g) of clause (vii) of sub-paragraph (5) | AC mains frequency variations | Applicable | Applicable | |
| 14. | Sub-clause (h) of clause (vii) of sub-paragraph (5) | Low voltage of internal battery | Applicable | Applicable | |
| 15. | Sub-clause (i) of clause (vii) of sub-paragraph (5) | Power supply duration test | Applicable | Applicable | (ii) This shall consist of the repeatability test specified in sub-clause (a) of clause (v) of sub-paragraph (5). |
| 16. | Sub-clause (j) of clause (vii) of sub-paragraph (5) | Voltage variations of a road vehicle battery | Applicable | Applicable | consist of the repeatability test defined in sub-clause (a) of clause (v) of sub-paragraph (5). |
| 17. | Sub-clause (k) of clause (vii) of sub-paragraph (5) | Hydrocarbons in the environment | Applicable | Applicable | |
| 18. | Sub-clause (l) of clause (vii) of sub-paragraph (5) | Raised fraction of CO2 in the test gas | Applicable | - | |
| 19. | Sub-clause (A) of clause (viii) of sub-paragraph (5) | Conducted (common mode) currents generated by RF EM fields | Applicable | Applicable | (i) Dry gases or gases without CO2 are allowed in combination with a preliminary repeatability test performed with wet gases. |
| 20. | Sub-clause (B) of clause (viii) of sub-paragraph (5) | Radiated RF electromagnetic fields | Applicable | Applicable | (ii) This shall consist of the repeatability test specified in sub-clause (a) of clause (v) of sub-paragraph (5). |
| 21. | Sub-clause (C) of clause (viii) of sub-paragraph (5) | Electrostatic discharges | Applicable | Applicable | |
| 22. | Sub-clause (D) of clause (viii) of sub-paragraph (5) | Bursts (transients) on AC and DC mains | Applicable | Applicable | |
| 23. | Sub-clause (E) of clause (viii) of sub-paragraph (5) | Surges on AC and DC mains power lines | Applicable | Applicable | |
| 24. | Sub-clause (F) of clause (viii) of sub-paragraph (5) | Bursts on signal, data and control lines | Applicable | Applicable | |
| 25. | Sub-clause (G) of clause (viii) of sub-paragraph (5) | Ripple on DC mains power | Applicable | Applicable | |
| 26. | Sub-clause (H) of clause (viii) of sub-paragraph (5) | DC mains voltage dips, short interruptions and (short term)variations | Applicable | Applicable | |
| 27. | Sub-clause (I) of clause (viii) of sub-paragraph (5) | AC mains voltage dips, short interruptions and voltage variations | Applicable | Applicable | |
| 28. | Sub-clause (J) of clause (viii) of sub-paragraph (5) | Surges on signal, data and control lines | Applicable | Applicable | |
| 29. | Sub-clause (K) of clause (viii) of sub-paragraph (5) | Electrical transient conduction along supply lines | Applicable | Applicable | |
| 30. | Sub-clause (L) of clause (viii) of sub-paragraph (5) | Electrical transient conduction via lines other than supply lines | Applicable | Applicable | |
| 31. | Sub-clause (M) of clause (viii) of sub-paragraph (5) | Mechanical shock | Applicable | Applicable | |
| 32. | Sub-clause (N) of clause (viii) of sub-paragraph (5) | Shakes | Applicable | Applicable | |
| 33. | Sub-clause (O) of clause (viii) of sub-paragraph (5) | Damp heat cyclic (condensing) | Applicable | |
| 34. | Sub-clause (P) of clause (viii) of sub-paragraph (5) | Storage test | Applicable | |
| 35. | Sub-clause (Q) of clause (viii) of sub-paragraph (5) | Vibration (as disturbance) | Applicable | Applicable | |
| 36. | Clause (ix) of sub-paragraph (5) | Physiological influence substances | Applicable | Applicable | (i) Dry gases or gases without CO2 are allowed in combination with a preliminary repeatability test performed with wet gases. |
| | | | | (ii) This shall consist of the repeatability test specified in sub-clause (a) of clause (v) of sub-paragraph (5). |
| 37. | Clause (i) of sub-paragraph (6) | Sand and dust | | Applicable | |
| 38. | Clause (ii) of sub-paragraph (6) | Salt mist | | Applicable | |
| 39. | Clause (iii) of sub-paragraph (6) | Water | | Applicable | |
(X) Some of the tests specified in clause (vi) of sub-paragraph (5) require a generator with the ability to vary the flowrate or alcohol concentration during breath exhalation. The actual performance details of the test gas evolution for each test are specified in sub-clause (a) clause (vi) of sub-paragraph (5). For all other tests, the flowrate and alcohol concentration shall be constant during injection.
(c) Guidelines for use of compressed dry gases: When compressed gases are used within the context of this specification, the following guidelines shall be followed, namely:–
(i) variations in atmospheric pressure and the temperature of the gas shall be taken into account;
(ii) the quality of the gas pressure regulators and the manner in which the gas is delivered to the EBA shall be taken into account to minimise contamination and a change in the composition of alcohol throughout its use cycle;
(iii) the measurement uncertainties of the test gas generator shall be taken into account in calculations of the uncertainties of the measurement;
(iv) the main component of the gas shall be dry air and, if any other gas, for example N2 , is used as the main component,the equivalence to air shall be established; and
(v) when working with dry test gas the atmospheric pressure has to be monitored and reported in the testprotocol.
(5) Performance tests: (i) General instructions:
(a) The tests specified in this Part are designed to prove compliance of the instrument with the requirements specified in paragraphs 1 to 4 of Part 1 and paragraphs 1 to 4 of this Part. For special situations, additional performance criteria and their associated tests shall be required in order to prove compliance.
(b) The instrument shall be submitted to the performance tests to determine its correct functioning under various conditions.
(c) Before starting the process of type evaluation the EBA shall be adjusted, if necessary, in order to minimise the initial intrinsic error.
(d) Thereafter, no adjustment shall be carried out until all tests for the type evaluation are completed.
(ii) Preconditions for the tests: Unless otherwise specified, the following preconditions shall apply for all tests:
(a) normal electric power supplied and ―on‖ for a time period equal to or greater than the warm—up time of the EUT;
(b) power supply for the duration of the test:
(I) the mains power-operated EUTs shall be ―on‖ for the duration of the test and not be switched off. When the EUT may enter standby mode after a specified idle time within the duration of the test;
(II) the battery-operated EUTs shall be as per to the instruction manual. The EUT may enter standby mode or ―off‖ after a specified idle time within the duration of the test;
(c) the EUT shall not be readjusted at any time during the test;
(d) the EUT shall be used in metrological test mode;
(e) the EUT shall perform standard measurement cycles and the use of special or shorted test cycles shall only be allowed if specified at the respective test in these rules;
(f) if the EUT is equipped with an internal printer, its correct function and correct printout shall be tested with each test specified in clause (vii) of this sub-paragraph to clause (iii) of sub-paragraph (6).
(iii) Parameters to be recorded: Unless otherwise specified, the following parameters shall be recorded for all tests, namely:–
a) date and time;
b) ambient temperature;
c) ambient relative humidity;
d) ambient pressure;
e) values of the measurand;.
f) indications and errors of the EUT;
g) functional performances; if applicable: and
h) correct printout of the internal printer.
Note: With ―functional performances‖ all laboratory-specific and test-specific issues shall be covered, for example settings of the test gas generator or parameters of specific test equipment.
(iv) Determination of errors and faults: To rate the effect of an influence factor or a disturbance on the EBA, the fault has to be determined in the following manner, namely:–
a) the intrinsic indication shall be determined as the arithmetic mean of the specified number of measurements under reference conditions without disturbance, as given in these specifications and, the intrinsic error will be the deviationbetween the intrinsic indication and the reference value;
b) the indication shall be determined as the arithmetic mean of the specified number of measurements during or after the impact of the influence factor or the disturbance, as given in these specifications and, the measurement error will be the deviation between the indication and the reference value;
c) the fault shall be determined as the difference between the measurement error and the intrinsic error.
(v) Accuracy tests:
(a) Maximum permissible errors and repeatability:
Table 7 - Maximum permissible errors and repeatability.
| Serial | Test method | Repeated measurements over the complete measuring range |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all EBA. |
| 2. | Object of the test. | Verification of compliance of the complete measurement range with the provisions in clause (i) of sub-paragraphs (6) and (7) of paragraph 1 under ambient reference conditions. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | The test comprises of at least 20 measurements made consecutively at each test gas concentration. |
| 5. | Test gases Mass concentration of ethanol. | Test gas no.: |
| | | (1) 0 mg/L to 0.05 mg/L2) 0.10 mg/L |
| | | (3) 0.25 mg/L |
| | | (4) 0.40 mg/L |
| | | (5) 0.70 mg/L |
| | | (6) 0.95 mg/L |
| | | (7) 1.50 mg/L |
| | | (8) 1.90 mg/L |
| | | (9) If the upper value specified by the manufacturer is greater than 2 mg/L, the test gas mass concentration shall be equal to 90 % of the upper limit. |
| 6. | Measurement conditions. | (i) Ethanol concentrations: see above. |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub clause (a) of clause (iii) of sub-paragraph (4), and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements per concentration: at least 20. |
| | | (ii) Time schedule: to be performed consecutively for each concentration. |
| | | (iii) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) Each of the 20 measurement results for every test gas concentration shall comply with the requirements for the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
| | | (iii) Each set of measurements shall comply with repeatability specified in sub-paragraph (7) of paragraph 1. |
(b) Drift:
Table 8 - Drift.
| Serial | Test method | Measurements with the same test gas after certain time intervals |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the requirements for drift |
| 3. | Precondition. | Other tests for type approval shall be performed during the time interval between the drift tests. |
| 4. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test at least during each set of measurements. (1) |
| 5. | Test procedure in brief. | (i) The tests comprise 10 subsequent measurements at the start and 10 subsequent measurements after the following time intervals,– |
| | | (a) For zero drift: 4 hours after the start |
| | | (b) For short-term drift: 4 hours after the start |
| | | (c) For long-term drift: every 2 weeks until the 6 months testing time is completed. |
| 6. | Measurement conditions. | (i) Ethanol concentrations: |
| | | (a) for zero drift: 0.00 mg/L to 0.05 mg/L (test gas no. 1) |
| | | (b) for short-term drift: 0.40 mg/L (test gas no. 4) |
| | | (c) for long-term drift: 0.40 mg/L (test gas no. 4) |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements per point in time: 10. |
| | | (ii) Time schedule: (a) at start |
| | | (b) as defined in ―test procedure in brief‖ |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) For the zero drift and the short-term drift test: The difference between the mean measurement errors of the two series of measurements shall fulfill the requirements for drift. |
| | | (ii) For the long-term drift: The difference between the mean measurement error of the start series and each mean measurement error of all intermediate series and the final series shall fulfill the requirementsfor long-term drift. |
(1) The EBA instruction manual shall be followed. The test situation shall correspond to the normal use of the respective EBA in the field. The testing laboratory shall note how any power— down or standby mode functions were operated between drift tests.
(c) Memory effects:
Table 9 - Memory effects.
| Serial | Test method | Measurement of different mass concentrations of ethanol in succession. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the requirements for memory effects (sub-paragraph (9) of paragraph 1) with large differences in mass concentration as well as with small differences in massconcentration. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The tests comprise of,- |
| | | (a) an initial test series with 10 subsequent measurements with the test gas with the lowerconcentration to determine the mean start value. |
| | | (b) then the EUT is subjected to a series of measurements with alternating concentrations: |
| | | (I) one measurement using the higher concentration, |
| | | (II) followed immediately by one measurement using the lower gas concentration. |
| | | (ii) this alternating test sequence shall be repeated 10 times. |
| | | (iii) for large differences in mass concentration: |
| | | (a) test gas number 7 is used in the event the maximum concentration of the measuring range ofthe EBA is 2 mg/L. |
| | | (b) Test gas number 8 shall be used when it is greater than 2 mg/L. |
| 5. | Measurement conditions. | (i) Ethanol concentrations: |
| | | Case 1: Large differences: |
| | | (a) high gas concentration: 1.50 mg/L (test gas no. 7) or 1.90 mg/L (test gas no. 8) |
| | | (b) low gas concentration: 0.10 mg/L (test gas no. 2) |
| | | Case 2: Small differences: |
| | | (a) high gas concentration: 0.40 mg/L (test gas no. 4) |
| | | (b) low gas concentration: 0.25 mg/L (test gas no. 3) |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4) of paragraph 6. |
| 6. | EUT performance. | (i) Number of alternating test sequences: 10. |
| | | (ii) Time schedule: consecutively at each test condition. |
| | | (iii) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 7. | Acceptance criteria. | (i) Each individual measurement shall comply with the MPE as specified in clause (i) of sub-paragraph (6) of paragraph 1. |
| | | (ii) The arithmetic mean of the initial test series results and the arithmetic mean of the results forthe lower concentration of the alternating cycle shall be calculated. The difference between these mean values shall fulfill the requirements for memory effects. |
(d) Effect of water vapour (condensation):
Table 10 - Effect of water vapour (condensation).
| Serial | Test method. | Measurement of different mass concentrations of ethanol in succession under specific |
| Number | | temperature conditions. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the requirements for memory effects - effect of water vapour. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The tests comprise of measurements with two different wet test gases at the specified lowambient temperature for the use-case type of Breath analysers. |
| | | (ii) Stabilising time at the low ambient temperature: at least 2 hours. |
| | | (iii) Test sequence: |
| | | (1) Ten measurements at 0.00 mg/L at the maximum rate permitted bythe EBA; |
| | | (2) Five measurements at 0.40 mg/L. |
| 5. | Measurement conditions. | (i) Ethanol concentrations: |
| | | (a) 0.00 mg/L (test gas no. 1); |
| | | (b) 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (a) of clause (iii) of the said sub paragraph. |
| | | (iii) Ambient conditions: |
| | | Use—case Temperature Relative humidity |
| | | stationary 0 °C a) 85 % |
| | | transportable –5 °C a) 85 % |
| | | portable –10 °C a) 85 % |
| | | (iv) All other parameters within reference conditions as specified in clause (i) of sub paragraph (4). |
| 6. | EUT performance. | (i) Number of measurements: for (1): 10 measurements; |
| | | for (2): 5 measurements. |
| | | (ii) Time schedule: (1) and (2) to be performed consecutively, both at the maximum rate permitted by the EBA. |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 7. | Acceptance criteria. | Each individual measurement shall comply with the MPE as specified in clause (i) of sub paragraph (6) of paragraph 1. |
(vi) Influence factors of the conditions of injection,—
(a) Variations of the test gas parameters,—
Table 11 - Variations of the test gas parameters.
| Serial | Test method. | Variations of the test gas parameters. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to all Breath analysers. |
| | | (ii) Test f) is applicable only to Breath analysers for which the minimum exhalation time (tmin) < 5 s (1) |
| 2. | Object of the test. | Verification of compliance with the analysis of end expiry breath (sub-paragraph (3) of paragraph 3 of Part—1) and the requirements for conditions of exhalation [clause (ii) of sub-paragraph (10) of paragraph 1 and clause (vii) of sub-paragraph (1) of paragraph 2] specified by the parameters: delivered volume; duration of the injection; variation of the flowrate as a function of time; variation of the alcohol concentration as a function of time. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Basic test procedure. | For each influence to be tested, two or more tests with different conditions are defined. For each test, at least five subsequent test |
| | | sequences shall be performed. |
| 5. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 6. | Influence (a) Influenceof delivered volume and duration of injection. | (i) Test gas generator: type 1 or type 2. |
| | | (a) Variation of the flowrate as a function of time: no variation. |
| | | (b) Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) plateau duration equal to 3 s (type 2 test gas generator). |
| | | (ii) First test: |
| | | (a) Delivered volume: 1.5 L ± 0.1 L |
| | | (b) Duration of the injection: 5 s ± 0.5 s |
| | | (iii) Second test: |
| | | (a) Delivered volume: 4.5 L ± 0.3 L |
| | | (b) Duration of the injection: 15 s ± 0.5 s. |
| | (b) Influenceof flowrate and of duration of injection. | (i) Test gas generator: type 1 or type 2 |
| | | (a) Variation of the flowrate as a function of time: no variation. |
| | | (ii) First test: Delivered volume: 1.5 L ± 0.1 L |
| | | (a)Duration of the injection: 10 s ± 0.5 s |
| | | (b)Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) plateau duration equal to 4.5 s (type 2 test gas generator). |
| | | (iii) Second test: |
| | | (a) Delivered volume: 3.0 L ± 0.2 L |
| | | (b) Duration of the injection: 15 s ± 0.5 s |
| | | (c) Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) plateau duration equal to 6 s (type 2 test gas generator). |
| | | (iii) Third test: |
| | | (a) Delivered volume: 4.5 L ± 0.3 L |
| | | (b) Duration of the injection: 7.5 s ± 0.5 s |
| | | (c) Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) plateau duration equal to 3.5 s (type 2 test gas generator). |
| 7. | (c) Influenceof flowrate during exhalation. | (i) Test gas generator: type 1 or type 2 |
| | | (a) Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) the same plateau duration in both tests (type 2 test gas generator). |
| | | (ii) First test: |
| | | (a) Delivered volume: 3.0 L ± 0.2 L |
| | | (b) Flowrate: 0.6 L/s ± 0.08 L/s |
| | | (c) Variation of flowrate as a function of time: no variation. |
| | | (iii) Second test: |
| | | (a) Delivered volume: 3.0 L ± 0.2 L |
| | | (b) Variation in the flowrate as a function of time: |
| | | (I) Initial flowrate: 0.6 L/s during 1.5 s |
| | | (II) between 1.5 s and 5 s the flowrate decreases to 0.2 L/s |
| | | (III) after 5 s, the flowrate remains equal to 0.2 L/s until the end of the injection. |
| | (d) Influenceof duration of the plateau during injection. | (i) Test gas generator: type 2 |
| | | (a) Variation of the flowrate as a function of time: no variation. |
| | | (ii) First test: |
| | | (a) Delivered volume: 3.0 L ± 0.2 L |
| | | (b) Duration of the injection:5 s ± 0.5 s |
| | | (c) Duration of the plateau: 3 s |
| | | (iii) Second test: |
| | | (a) Delivered volume: 3.0 L ± 0.2 L |
| | | (b) Duration of the injection: 5 s ± 0.5 s |
| | | (c) Duration of the plateau: 1.5 s |
| | (e) Influenceof an interruption in the breath flow. | (i) Test gas generator: type 1 or type 2 |
| | | (a) Variation of the alcohol concentration as a function of time: |
| | | (I) no variation (type 1 test gas generator); or |
| | | (II) plateau duration equal to 3 s (type 2 test gas generator). |
| | | (ii) First test: Abruption at the beginning of the exhalation |
| | | (a) Delivered volume: 2.0 L ± 0.2 L |
| | | (b) Duration of the injection:5 s ± 0.5 s |
| | | (c) Flowrate: 0.4 L/s ± 0.08 L/s |
| | | (d) Variation of the flowrate as a function of time: no variation. |
| | | (e) The injection shall be stopped 1 s ± 0.5 s after the start of the injection. |
| | | (iii) Second test: verification of the minimum exhaled volume |
| | | (a) Flowrate: 0.2 L/s ± 0.02 L/s |
| | | (b) Duration of the injection: 15 s ± 0.5 s |
| | | (c) Variation of the flowrate as a function of time: no variation. |
| | | (d)The injection shall be stopped at 6 s ± 1 s after the start (delivered volume <1.2 L). |
| | | (iv) Third test: Verification of the detection of the end of exhalation |
| | | (a) Flowrate: 0.15 L/s ± 0.02 L/s |
| | | (b) The injection of a gas shall be supplied at a flowrate of 0.15 L/s for 6 s ± 1 s,and then decreased fast (within 1 s to 2 s) to a flowrate of 0.03 L/s to determine the ―end of exhalation‖ of the EUT. |
| | | (v) Fourth test: Short flow interruption. |
| | | (a) Flowrate: 0.4 L/s ± 0.08 L/s |
| | | (b) The injection shall be interrupted after 1 to 2 s for a short period (for example 0.5 s),and then continued. |
| | (f) Operationat the minimum exhaled volume and minimum exhalation time (tmin) (1). | (i) Test gas generator: type 1 or type 2 |
| | | (a) Variation of the flowrate as a function of time: no variation |
| | | (b) Variation of the alcohol concentration as a function of time: no variation |
| | | (c) Flowrate: 0.4 L/s ± 0.08 L/s |
| | | (d) Delivered volume: 1.2 L to 1.3 L |
| | | (ii) First test: |
| | | (a) Duration of the injection: (tmin– 0.5 s) ± 0.4 s |
| | | (iii) Second test: Duration of the injection: tmin (2) |
| 8. | EUT performance. | (i) Number of test sequences per test condition: at least 5. |
| | | (ii) Time schedule: consecutively at each test condition. |
| | | (iii) Parameters at least to be recorded: as defined in clause (iii) of sub-paragraph (5). |
| 9. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (a) For test conditions (a) to (d): |
| | | (I) Each measurement result shall comply with the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
| | | (b) For test condition (e) |
| | | (I) The EBA shall not provide a measurement result. No significant fault shall occur. |
| | | (c) For test condition (f): |
| | | (I) First test: The EBA shall not accept a measurement with a duration of injection shorterthan tmin. |
| | | (II) Second test: Each measurement result shall comply with the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(1) tmin shall be 3 s as specified in clause(ii) of sub-paragraph (10) of paragraph 1 or a value between 3 s and 5 s according to themanufacturer.
(2) It has to be ensured that the delivered volume shall be ≥ 1.2 L, taking into account the uncertainties of measuring flowrate and duration of injection.
(b) Alcohol in the upper respiratory tract:
(I) Depending on which solution is prescribed for the detection of alcohol in the upper respiratory tracts, a suitable test procedure has to be performed.
(II) Examples for possible methods of detection and the corresponding test procedures shall be found in Annexure B. The choice of detection method is the responsibility of the manufacturer who shall fit the detection method to the technical details of the EBA to be tested.
(III) Different method of detection and a different test procedure may be used provided that validity shall be demonstrated and the test procedure documented in detail. All test procedures shall follow the basic requirements for test performance as givenin Table 12.
(IV) The test procedure applied by the testing laboratory shall be reported in detail in the Evaluation Report.
Table 12 - Basics of a test procedure for alcohol in the upper respiratory tract.
| Serial | Test method | Measurements to detect ethanol in the upper respiratory tract |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions under ambient reference conditions. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | Depending on the test procedure chosen. |
| 5. | Measurement conditions | As provided in Annexure B. |
| 6. | EUT performance. | (i) Number of measurements per test scheme: depending on the test procedure. |
| | | (ii)Time schedule: depending on the test procedure. |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 7. | Acceptance criteria. | (i) The EUT shall detect the presence of alcohol in the upper respiratory tract. |
| | | (ii) It shall not deliver any measurement result and shall display an appropriate error message. |
(vii) Tests for operating conditions and physical influence factors:
(a) Temperature test (dry heat and cold):
Table 13 - Temperature test (dry heat and cold).
| Serial | Test method | Gradual exposure to high and low temperatures not allowing condensation to occur |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance of provisions of clause (i) of sub-paragraph (6) of paragraph 1 under conditions of high and low temperature specified at serial number (a) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises gradual exposure of the EUT to high and low temperatures not allowingcondensation to occur. |
| | | (a) Climatic condition: ―free air‖ (= sufficient air circulation to maintain the temperature at a stable level). |
| | | (b) Change of temperature: ≤10C/min during heating up and cooling down. |
| | | (c) Stabilising time at each temperature: at least 2 hours. |
| | | (d) Time of exposure: at least 2 hours after the EUT has reached temperature stability. |
| | | (ii) Test sequence: |
| | | (I) Reference temperature of TR (1) |
| | | (II) Specified high temperature Tamb-high |
| | | (III) Specified low temperature Tamb-low |
| | | (IV) Reference temperature TR (1) |
| 5. | Test levels. | Temperature | relative humidity |
| | | Low (Tamb-low) | stationary EBA 0 °C | ≤50 % |
| | | | transportable EBA –5 °C | ≤50 % |
| | | | portable EBA –10 °C | ≤50 % |
| | | High (Tamb-high) | stationary EBA 40 °C | ≤30 % |
| | | | transportable EBA 45 °C | ≤30 % |
| | | | portable EBA 45 °C | ≤30 % |
| 6. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: |
| | | (a) delivered volume: 1.5 L ± 0.1 L |
| | | (b) duration of injection: 5 s ± 0.5 s |
| | | (c) all other parameters as specified in Table 4 of sub-clause (a) of clause (iii) of sub paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (d) Ambient conditions: temperature and humidity at the respective test level, all other parameters within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements per temperature: 5. |
| | | (ii) Time schedule: after stabilisation, towards the end of exposure time at each temperature |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) All errors shall be within the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(1) Default reference temperature: TR = 20 °C.
(b) Damp heat, steady state (non-condensing):
Table 14 - Damp heat, steady-state (non-condensing).
| Serial | Test method. | Exposure to damp heat in steady-state. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers, except those stationary Breath analysers which are expected to be used only in a climate-controlled environment. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in clause (i) of sub-paragraph (6) of paragraph 1 under conditions of high humidity and constant temperature, specified in clause a ―High‖and serial number (b) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the specified high level temperature and thespecified constant relative humidity for 48h (2 × 24 h). |
| | | (ii) The EUT shall be handled such that condensation of water on the EUT does not occur. |
| | | (iii)Test sequence: |
| | | (a) Specified temperature and relative humidity |
| | | (b) Reference conditions |
| | | Stationary Breath analysers | Transportable Breath analysers | Portable Breath analysers |
| | Ambient temperature | 40 °C | 45 °C | 45 °C |
| | Relative humidity | 85 % | | |
| | Duration | 2 periods of 24 hours after the EUT has reached temperature stability. |
| 5. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: temperature and humidity at the respective test level, all other parameters within reference conditions as specified in sub-clause (a) of clause (iii) of sub-paragraph (4). |
| 6. | EUT performance. | (i) Number of measurements and time schedule: |
| | | (a) during exposure: 5 measurements every 24 hours at test conditions |
| | | (b) after exposure: after a recovery period of one hour, 5 measurements at reference conditions. |
| | | (ii) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 7. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The error of the EUT is determined for each set of measurements. |
| | | (iii) All errors shall be within the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1 . |
(c) Static atmospheric pressure:
Table 15 — Static atmospheric pressure.
| Serial | Test method. | Exposure to low and high atmospheric pressure. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in clause (i) of sub paragraph (6) of paragraph 1 under conditions of static atmospheric pressure changes to upper and lower limit specified in serial number (c) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the specified upper and lower atmosphericpressures limits. |
| | | (ii) Exposure is to be established for at least 10 minutes at each pressure. |
| | | (iii) Test sequence: |
| | | (a) Specified lower pressure limit; |
| | | (b) Specified upper pressure limit; |
| | | (c) Reference conditions. |
| | Test level. | Atmospheric pressure |
| | Lower limit | (860 ± 10) hPa |
| | Upper limit | (1060 ± 10) hPa |
| | Uncertainty of the pressure sensor | 1.50 hPa |
| 5. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub—paragraph (4) and Table 6 under sub-clause (a) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: ambient pressure at respective test level, all other parameters within reference conditions as specified in clause (i) of sub-paragraph (4) of paragraph 6. |
| 6. | EUT performance. | (i) Number of measurements at each pressure level: 5. |
| | | (ii) Time schedule: after stabilisation at the respective pressure. |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5) of paragraph 6. |
| 7. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) All errors shall be within the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(d) Random vibration:
Table 16 - Random vibration.
| Serial | Test method | Exposure to random vibration. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to portable and transportable Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in clause (i) of sub paragraph (6) of paragraph 1 under conditions of random vibration specified at serial number (d) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | (i) Power is to be ―off‖ for the duration of the exposure. |
| | | (ii) The EUT shall be switched on immediately after the exposure. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the vibration for at least 2 minutes per axis. The EUT shall subsequently be tested in three mutually perpendicular axes mounted on a rigid fixture by its normal mounting means. |
| | | (ii) The EUT shall normally be mounted in such a way that the gravity vector points in the samedirection as it would in normal use. |
| | | (iii) If the measurement principle is such that the effect of the direction of the gravity vector shall beconsidered negligible, the EUT shall be mounted in any position. |
| | | (iv) Test sequence: |
| | | (a) Measurements before application of the influence (at reference conditions) |
| | | (b) The influence quantity shall be applied |
| | | (c) Measurements after application of the influence (at reference conditions). |
| 5. | Test level. | Test level |
| | Total frequency range | 10 – 150 Hz |
| | Total RMS level (mean value of acceleration) | 7 m·s—2 |
| | ASD level 10–20 Hz | 1 m2·s—3 |
| | ASD level 20–150 Hz | –3 dB/octave |
| | Duration per axis | For each of the orthogonal directions the vibration exposure time shall be 2 minutes. |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: ambient pressure at respective test level, all other parameters within reference conditions as defined in clause (i) of sub paragraph (4) of paragraph 6. |
| 7. | EUT performance. | (i) Number of measurements (before and after application): 5. |
| | | (ii) Time schedule: before and after application of the influence quantity, the EUT shall be switched on and the measurements shall be performed consecutively after stabilisation. |
| | | (iii) Parameters at least to be recorded: as defined in clause (iii) of sub paragraph (5) of paragraph 6. |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The error of the EBA is determined at the reference conditions before and after the influence isapplied. |
| | | (iii) All errors shall be within the MPE specified in clause (i) of sub paragraph (6) of paragraph 1. |
(e) DC mains voltage variations:
Table 17 - DC mains voltage variations.
| Serial | Test method | Applying low and high level DC mains power voltage. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to those Breath analysers which are designed to be temporarily or permanently connected to a DC mains power network while in operation. Not applicable to equipment powered by a roadvehicle battery. |
| 2. | Object of the test. | Verification of compliance with the provisions for maximum permissible error in clause (i) of sub-paragraph (10) of paragraph 1 under conditions of DC mains power voltage changes between the upper and lower limits specified at serial number (e) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the specified power supply condition for a period oftime sufficient for achieving stability at the given voltage level and subsequently performingthe required measurements. |
| | | (ii) Test sequence: |
| | | (a) Reference voltage level |
| | | (b) Upper voltage level |
| | | (c) Lower voltage level |
| | | (d) Reference voltage level |
| 5. | Test level. | Applied DC operating range | As specified by the manufacturer, but not less than (Unom – 15 %) ≤ Unom ≤ (Unom + 10 %). |
| | Reference voltage level | Nominal DC voltage specified by the manufacturer. |
| | Upper voltage limit | DC level at which the EUT has been designed to automatically detect high—level conditions. |
| | Lower voltage limit | DC level at which the EUT has been designed to automatically detect low—level conditions. |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas number 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at each voltage level: 5. |
| | | (ii) Time schedule: after stabilisation at the given voltage level. |
| | | (iii)Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5) of paragraph 6, and |
| | | (b) reference voltage at beginning and end, high voltage and low voltage. |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the reference voltage, the upper voltage and thelower voltage. |
| | | (iii) All errors shall be within the maximum permissible error specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(f) AC mains voltage variations:
Table 18 - AC mains voltage variations.
| Serial | Test method | Applying low and high level AC mains power voltage (on a single phase). |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to Breath analysers that are designed to be temporarily or permanently connected to anAC mains power network while in operation. |
| | | (ii) Not applicable to transportable Breath analysers which are powered by a road vehicle battery unless an external DC to AC conversion device is required while in operation. |
| 2. | Object of the test. | Verification of compliance with the provisions for maximum permissible error in clause (i) of sub-paragraph (6) of paragraph 1 under conditions of AC mains network voltage changes between the upper and lower limits specified at serial number (f) of Table 2 of sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the lower and upper limit power supply conditions for a period of time sufficient for achieving stability at the given voltage level and subsequently performing the required measurements. |
| | | (ii) Test sequence: |
| | | (a) Reference voltage level |
| | | (b) Upper voltage level |
| | | (c) Lower voltage level |
| | | (d) Reference voltage level. |
| | | (iii) In the case of three—phase power supply, the voltage variation shall apply for each phase successively. |
| 5. | Test levels. | Unom | Nominal AC voltage specified by the manufacturer |
| | If a range is specified by the manufacturer | Unom1 concerns the highest value |
| | | Unom2 concerns the lowest value |
| | If only one nominal mains voltage value (Unom) is specified by the manufacturer | then Unom1 = Unom2 = Unom |
| | Reference voltage level | (Unom1 + Unom2) / 2 |
| | Upper level | Unom1 + 10 % |
| | Lower level | Unom2 – 15 % |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as defined in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements per voltage level: 5. |
| | | Time schedule: after stabilisation at the given voltage level. |
| | | (ii) Parameters to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5) of paragraph 6 and |
| | | (b) reference voltage at beginning and end, high voltage and low voltage. |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the reference voltage, the upper voltage and thelower voltage. |
| | | (iii) All errors shall be within the maximum permissible error specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(g) AC mains frequency variations:
Table 19 - AC mains frequency variations.
| Serial | Test method | Variation in AC mains power frequency. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Only applicable to those Breath analysers which are designed to be temporarily or permanently connected to an AC power network while in operation. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in Clause (i) of sub-paragraph (6) of paragraph 1 under conditions of AC mains network power frequency changes between upper and lower limit specified at serial number (g) of Table 2 of sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to a variation in AC mains power frequency for a period of time sufficient for achieving stability at the given frequency level and for performing the required measurements. |
| | | (ii) Test sequence: |
| | | (a) Reference frequency; |
| | | (b) Upper frequency; |
| | | (c) Lower frequency; |
| | | (d) Reference frequency. |
| 5. | Test levels. | fnom | Nominal mains frequency value as specified by the manufacturer. |
| | If a range is specified by the manufacturer | fnom1 concerns the highest and |
| | | fnom2 concerns the lowest value. |
| | If only one nominal mains frequency value (fnom)is specified by the manufacturer | fnom1 = fnom2 = fnom |
| | Reference frequency | (fnom1 + fnom2) / 2 |
| | Upper level | fnom1 + 2 % |
| | Lower level | fnom2 - 2 % |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) umber of measurements per frequency level: 5. |
| | | (ii) Time schedule: after stabilisation at the given frequency level. |
| | | (iii) Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5) of paragraph, and |
| | | (b) reference frequency at beginning and end, high frequency and low frequency. |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the reference frequency, the upper frequency andthe lower frequency. |
| | | (iii) All errors shall be within the MPE specified in clause (i) of sub paragraph (6) of paragraph 1. |
(h) Low voltage of internal battery:
Table 20 - Low voltage of internal battery (not connected to the mains power).
| Serial | Test method. | Applying minimum supply voltage. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers supplied by an internal battery while in operation. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in Clause (i) of sub-paragraph (6) of paragraph 1 during low battery voltage specified at serial number (h) of Table 2 of sub-paragraph (10) of paragraph 1. |
| 3. | Precondition. | (i) The maximum internal impedance of the battery and the minimum battery supply voltage level (Ubmin) are to be specified by the manufacturer of the instrument. |
| | | (ii) If an alternative power supply source is applied instead of the internal battery, the internal impedance of the specified type of battery shall also be simulated. The alternative power supply shall be capable of delivering sufficient power at the required supply voltage. |
| | | (iii) The electrical power is supplied to the equipment under test and switched on for a time period of at least the warm-up time specified by the manufacturer. |
| 4. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 5. | Test procedure in brief. | (i) The test comprises exposure of the equipment under test to the specific low battery level condition during a period of time sufficient for achieving stability at the given voltage level and for performing the required measurements. |
| | | (ii) Test sequence: |
| | | (a) Reference voltage level; |
| | | (b) Lower voltage level; |
| | | (c) 0.9 × lower voltage level; |
| | | (d) Reference voltage level. |
| 6. | Test level. | Ubmin | Lower limit of the voltage | The lowest voltage at which the equipment under test functions properly according to the specifications (Ubmin). |
| 7. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as defined in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 of sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as defined in clause (i) of sub-paragraph (4) of paragraph 6. |
| 8. | EUT performance. | (i) Number of measurements at each voltage level: 5. |
| | | (ii) Time schedule: after stabilisation at the given voltage level. |
| | | (iii) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 9. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) At 0.9 × Ubmin: the equipment under test shall either: |
| | | (a) cease to function (turn itself off); |
| | | (b) not allow any measurements and give an appropriate error message; or |
| | | (c) shall measure correctly. |
| | | (iii) In case c the voltage shall be reduced until case a or b does occur. |
| | | (iv) The errors of the equipment under test shall be determined for the lower voltage level(s) and the referencevoltage level. |
| | | (v) All errors shall be within the maximum permissible error specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(i) Power supply duration test:
Table 21 - Power supply duration test.
| Serial | Test method. | Consecutive measurements of mass concentrations of ethanol under |
| Number | | specific temperature conditions. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to portable Breath analysers powered by internal batteries. |
| 2. | Object of the test. | Verification of compliance with the requirements for power supply duration (battery) |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The tests comprise of repeated measurements at different ambient conditions starting with a fullycharged internal battery. |
| | | (ii) Test sequence: |
| | | (a) Complete charging of rechargeable batteries, or replacement of non rechargeablebatteries to a new set. |
| | | (b) 50 individual measurements at reference ambient conditions with a test gasconcentration of 0.40 mg/L. |
| | | (c) Exposure to –10 °C, with a stabilising time of at least 2 hours. |
| | | (d) 20 individual measurements at an ambient temperature of –10 °C, with a test gas concentration of 0.40 mg/L. |
| 5. | Measurement conditions. | (i) Ethanol concentrations: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: for (ii): reference conditions as specified in clause (i) of sub-paragraph (4). |
| | | for (iii): ambient temperature: –10 °C, all other parameters within reference conditions as specified in clause (i) of sub-paragraph(4). |
| 6. | EUT performance. | (i) Number of measurements: |
| | | (a) for test sequence no. (ii): 50 |
| | | (b) for test sequence no. (iv):20 |
| | | (ii) Time schedule: consecutively |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub paragraph (5). |
| 7. | Acceptance criteria. | (i) Each individual measurement shall comply with the maximum permissible error as specified under clause (i) of sub-paragraph (6) of paragraph 1. |
| | | (ii) The EBA shall be capable of performing all the tests on one set of batteries or a single charge of batteries. |
(j) Voltage variations of a road vehicle battery:
Table 22- Voltage variations of a road vehicle battery.
| Serial | Test method. | Variation in supply voltage |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all transportable or portable Breath analysers supplied by the on-board battery of a vehicle which shall at the same time be charged by use of a combustion engine driven generator. |
| 2. | Object of the test. | Verification of compliance with the provisions for maximum permissible error in clause (i) of sub-paragraph (6) of paragraph 1 under conditions of high (while charging) and low battery voltage specified at serial number (i) of Table 2 under clause (i) of sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to the specified maximum and minimum power supplyvoltage conditions for a period of time sufficient for achieving stability at the given voltage level and performing the required measurements at these conditions. |
| | | (ii) Test sequence: |
| | | (a) Upper voltage level; |
| | | (b) Lower voltage level; |
| | | (c) Reference voltage level. |
| 5. | Test level. | Nominal battery voltage | Unom = 12 V | Unom = 24 V |
| | | Lower limit | Upper limit | Lower limit | Upper limit |
| | | 9 V | 16 V | 16 V | 32 V |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4) |
| 7. | EUT performance. | (i) Number of measurements per voltage level: 5. |
| | | (ii) Time schedule: after stabilisation at the given voltage level. |
| | | (iii) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the upper voltage level, for the lower voltagelevel and for the reference voltage level. |
| | | (iii) All errors shall be within the MPE specified in clause (i) of sub paragraph (6) of paragraph 1. |
(k) Hydrocarbons in the environment:
Table 23 - Hydrocarbons in the environment.
| Serial | Test method. | Exposure to an environment containing hydrocarbons. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in clause (i) of sub-paragraph (6) of paragraph 1 under conditions of exposure to the level of hydrocarbons in the environment specified at serial number (j) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to a simulated environment containing a specificfraction of hydrocarbons. |
| | | Test sequence: |
| | | (a) Measurements at influence conditions; |
| | | (b) Measurements at reference conditions. |
| 5. | Test level. | Volume fraction of hydrocarbons (as methane equivalent) | 5 ppm ± 1 ppm |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) under clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements per condition: 5. |
| | | (ii) Time schedule: consecutively at each test condition after stabilisation at the given condition. |
| | | (iii) Parameters to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5); and |
| | | (b) type and volume fraction of applied hydrocarbons. |
| 8. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the influence condition and for the reference condition. All errors shall be within the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(l) Raised fraction of CO2 in the test gas:
Table 24 - Raised fraction of CO2 in the test gas.
| Serial | Test method. | Measurements with raised CO2-content in the test gas |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for MPE in clause (i) of sub-paragraph (6) of paragraph 1 under conditions of raised CO2 in the test gas as specified at serial number (k) of Table 2 under sub-paragraph (10) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises of 5 measurements with a test gas with raised CO2—content and 5 measurements with a standard test gas, both of the same ethanol concentration. |
| | | (ii) Test sequence: |
| | | (a) Measurements with test gas with raised CO2-content; |
| | | (b) Measurements with standard test gas. |
| 5. | Measurement conditions. | (i) Ethanol concentrations: |
| | | 0.40 mg/L (test gas no. 4) with 80 mmol/mol CO2 |
| | | 0.40 mg/L (test gas no. 4) with 50 mmol/mol CO2 (standard test gas). |
| | | (ii) Test gas conditions: CO2—concentration as specified above, all other parameters within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 6. | Equipment under test performance. | (i) Number of measurements per test gas: 5. |
| | | (ii) Time schedule: consecutively with each test gas. |
| | | (iii) Parameters at least to be recorded: as specified in clause (iii) of sub paragraph (5). |
| 7. | Acceptance criteria. | (i) All functions shall operate as designed. |
| | | (ii) The errors of the EUT shall be determined for the influence condition and the reference condition. All errors shall be within the MPE specified in clause (i) of sub-paragraph (6) of paragraph 1. |
(viii) Disturbances tests:
(A) Conducted (common mode) currents generated by radio frequency electromagnetic (RF EM) fields: (a) This test in metrological test mode requires a substantial amount of test time and to keep the test time within a reasonable time frame, one of the following test schemes (A) or (B) shall be applied.
(b) The procedure provided by the manufacturer shall be approved and the manufacturershall provide the documentation to justify its procedure. The method applied by the testing laboratory to coverthe frequency range shall be reported in detail in the Evaluation Report.
(i) Test scheme (A): (a) Apart from the metrological test mode, the manufacturer shall implement a special test mode to reduce the test time, which mode shall cover all possible influences caused by disturbances.
(b) All output signals of the sensors shall be monitored after determining what the influence on the measurement result will be. All these signals shall have their own MPE (to be determined accordingly) and the manufacturer shall provide all the necessary information.
(c) Alternatively, the algorithm used in normal operation to calculate the measurement result shall be used for combining the signals of the sensors to indicate a measurement result in units of alcohol mass concentration.
(d) For this special test mode, the testing procedure applied by the testing laboratory shall be discussed with the manufacturer, who shall provide the means (monitoring system) and determine which sensors are giving correct measurements (with the MPE).
(d) If a deviation is detected on any output signal at one frequency, 5 measurements (of ethanol concentration) in metrological test mode shall be performed at this frequency.
(e) If no deviation is detected, at least 5 measurements (of ethanol concentration) in metrological test mode shall be conducted during the frequency range (see test level) at the maximum test frequency permitted by the EBA.
(ii) Test scheme (B): (a) The instrument performs the measurements in metrological test mode consecutively until stopped while it is exposed to the disturbance. Measuring ambient air for zero-setting is considered as part of the measurements and the time between each measurement has to be taken into account during the disturbance test.
Table 25 - Conducted (common mode) currents generated by radio frequency electromagnetic (RF EM) fields.
| Serial | Test method | Injection of radio frequency currents representing exposure to radio |
| Number | | frequency electromagnetic fields. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all those Breath analysers that are or shall be equipped with external electrical wiring (mains power, signal, data and control lines). |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in sub paragraph (11) of paragraph 1 while exposed to electromagnetic fields specified at serial number (a) of Table 3 under the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) An RF EM current, simulating the influence of EM fields shall be coupled or injected into the power ports and input or output (I/O) ports of the equipment under test using coupling or decoupling devices as specified in the international standard IEC 61000-4-6 [26]. |
| | | (ii) The characteristics of the test equipment consisting of an RF generator, (de-) coupling devices, attenuators, etc. shall be verified before connecting the equipment under test. |
| | | (iii) If the equipment under test comprises several devices, the tests shall be performed at each extremity of the cable if both of the elements are part of the equipment under test. |
| | | (iv) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Frequency range | RF amplitude | AM, sine wave |
| | | | | modulation |
| | | 0.15 MHz – 80 MHz | 10 V (e.m.f.) | 80 % | 1 kHz |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): Depending on the actual test setup. |
| | | (iii) Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5) ; and |
| | | (b) applied RF [electromotive force (e.m.f)] voltage level. |
| 8. | Acceptance criteria. | (i) Test scheme A: |
| | | (a) All output signals shall be within their own MPE. |
| | | (b) For the measurement of ethanol concentration, the Test scheme B acceptance criteria shall be applied. |
| | | (ii) Test scheme B: |
| | | (a) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (b) Either significant faults do not occur or checking facilities detect and act on potential significant faults, thereby preventing such faults from occurring. |
| | | (iii) It is acceptable that during the disturbance test the EUT does not provide a measurement result. |
(B) Radiated RF electromagnetic fields:
(a) This test in metrological test mode requires a substantial amount of test time and to keep the test time within a reasonable limit, one of the following test schemes (A) or (B) shall be applied.
(b) The procedure provided by the manufacturer shall be approved and the manufacturershall provide the documentation to justify its procedure. The method applied by the testing laboratory to coverthe frequency range shall be reported in detail in the Evaluation Report.
(i) Test scheme (A): (a) Apart from the metrological test mode, the manufacturer shall implement a special test mode to reduce the testtime and this shall cover all the possible influences caused by disturbances.
(b) All output signals of the sensors shall be monitored after determining what the influence on the measurement result will be. All these signals shall have their own MPE (to be determined accordingly) and the manufacturer shall provide all the necessary information.
(c) Alternatively, the algorithm used in normal operation to calculate the measurement result shall be used for combining the signals of the sensors to indicate a measurement result in units of alcohol mass concentration.
(d) For this special test mode, the testing procedure applied by the testing laboratory shall be discussed with the manufacturer, who shall provide the means (monitoring system) and determine which sensors are giving correct measurements (with the MPE).
(d) If a deviation is detected on any output signals at one frequency, 5 measurements (of ethanol concentration) in metrological test mode shall be performed at this frequency.
(e) If no deviation is detected, at least 5 measurements (of ethanol concentration) in metrological test mode shall be conducted during the frequency range (see test level) at the maximum test frequency permitted by the EBA.
(ii) Test scheme (B): (a) The instrument performs the measurements in metrological test mode consecutively until stopped while it is exposed to the disturbance. Measuring ambient air for zero-setting is considered as part of the measurements and the time between each measurement has to be taken into account during the disturbance test.
Table 26 - Radiated RF electromagnetic fields.
| Serial | Test method. | Exposure to radiated radio frequency electromagnetic fields. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in sub paragraph (11) of paragraph 1 under conditions of exposure to electromagnetic fields specified at serial number (a) of Table 3 under the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. The electrical power supplied to the EUT shall not be switched off except for a reset when a significant fault has been indicated. |
| 4. | Test procedure in brief. | (i) The EUT is exposed to electromagnetic fields with the required field strength and the field uniformity as specified in the international standard IEC 61000-4-3 [23] and IEC 61000-4-20 [29]. The level of field strength specified refers to thefield generated by the un modulated carrier wave. |
| | | (ii) The EUT shall be exposed to the modulated wave field. The frequency sweep shall be made only pausing to adjust the RF signal level or to switch RF—generators, amplifiers and antennas if necessary. Where the frequency range is swept incrementally, the step size shall not exceed 1 % of the preceding frequency value. |
| | | (iii) The dwell time of the amplitude modulated carrier at each frequency shall not be less than the time necessary for the EUT to respond, but shall in no case be less than 0.5 s. |
| | | (iv) Adequate EM fields shall be generated in facilities of different type and setup, the use of which is limited by the dimensions of the EUT and the frequency range of the facility. |
| | | (v) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Frequency range. | RF amplitude. | AM, sine wave modulation. |
| | | 26 MHz – 80(1) MHz | 10 V/m | 80 % | 1 kHz |
| | | 80 MHz – 6 000 MHz | 10 V/m | 80 % | 1 kHz |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): Depending on the actual test setup.Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5) ; and |
| | | (b) field strength level. |
| 8. | Acceptance criteria. | (i) Test scheme A: All output signals shall be within their own maximum permissible error. For the measurement of ethanol concentration, the Test scheme B acceptancecriteria shall be applied. |
| | | (ii) Test scheme B: The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). Either significant faults do not occur, or checking facilities detects and act on potential significant faults, thereby preventing such faults from occurring. |
| | | (ii) It is acceptable that during the disturbance test the EUT does not provide a measurement result. |
(1) Only applicable where the instrument does not employ any cable or cable connection.
(C) Electrostatic discharges:
Table 27 - Electrostatic discharges.
| Serial | Test method. | Exposure to electrostatic discharges (ESD). |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in sub paragraph (11) of paragraph 1 in the case of direct exposure to electrostatic discharges or such discharges in the neighborhood of the EUT specified at serial number (b) of Table 3 under the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to electrical discharges. |
| | | (ii) An ESD generator as specified in the international standard IEC 61000-4-2 [22] shall be used and the test setup shall comply with the dimensions, materials used and conditions made in these rules. Before starting the tests, the performance of the generator shall be verified. |
| | | (iii) An EUT not equipped with a safety ground connection shall first be fully discharged beforeexposure to the following discharge, namely:– |
| | | (a) At least 10 discharges per preselected discharge location shall be applied. |
| | | (b) The number of points of application on each surface will depend on the size of the instrument and the tested points shall be described in the test report. |
| | | (c) Contact discharge is the preferred test method. Air discharge is far less defined and reproducible and shall be used only where contact discharge shall not be applied. |
| | | (iv) Direct application: |
| | | (a) In the contact discharge mode to be carried out on conductive surfaces, the electrode shall be in contact with the EUT before activation of the discharge. In such cases the discharge spark occurs in the vacuum relays of the contact discharge tip. |
| | | (b) On insulated surfaces only the air discharge mode shall be applied and the EUT isapproached by the charged electrode until a spark discharge occurs. |
| | | (v) Indirect application: The discharges are applied in the contact mode only on coupling planes mounted in thevicinity of the EUT. |
| | | (vi) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Charge voltage | Contact discharge: 6 kV. |
| | | | Air discharge: 8 kV. |
| | Time interval between successive discharges: | At least 1 s |
| | Number of discharges per preselected discharge location: | At least 10 |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified under clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii)Number of measurements (during disturbance): 5. |
| | | (iii) Parameters to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5); and |
| | | (b) discharge type, level and surface. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults, thereby preventing such faults from occurring. |
| | | (iii) It is acceptable that during the disturbance test the EUT does not provide a measurement result. |
(D) Bursts (transients) on AC and DC mains:
Table 28 - Bursts (transients) on AC and DC mains.
| Serial | Test method. | Introducing transients on the mains power lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to those Breath analysers which are designed to be temporarily or permanently connected to amains power network while in operation. |
| | | (ii) Not applicable to transportable Breath analysers powered by a road vehicle battery. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in sub-paragraph (11) of paragraph 1 during conditions where electrical bursts are superimposed on the mains voltage specified at serial number (c) of Table 3 under the said sub paragraph . |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to bursts of voltage spikes for which the output voltage on 50 Ω and 1000 Ω load are specified in international standard IEC 61000-4-4 [24]. |
| | | (ii) A burst generator as specified in international standard IEC 61000-4-4 [24]. |
| | | (iii) The characteristics of the generator shall be verified before connecting the EUT and both positiveand negative polarity of the bursts shall be applied. |
| | | (iv) The injection network on the mains shall contain blocking filters to prevent the burst energyfrom being dissipated in the mains. |
| | | (v) At least 10 positive and negative randomly phased bursts shall be applied. |
| | | (vi) The bursts are applied during all the time necessary to perform the test, accordingly more burststhan indicated above shall be necessary. |
| | | (viii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Amplitude (peak value) | 1 kV. |
| | Repetition rate | 5 kHz. |
| | Duration of the test for each amplitude and polarity. | ≥1 min |
| | Number of bursts (each for positive and negative | 10. |
| 6. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii)Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria | (i) The errors and fault of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur, or checking facilities detect and act on potentialsignificant faults, thereby preventing such faults from occurring. |
| | | (iii) During the disturbance test the EUT may not provide a measurement result. |
(E) Surges on AC and DC mains power lines:
Table 29 - Surges on AC and DC mains power lines.
| Serial | Test method. | Introducing electrical surges on the mains power lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Only applicable to those Breath analysers which are designed to be temporarily or permanently connected toa mains power network while in operation. Not applicable to Breath analysers that are only designed to be connected to a local power source through an indoor network or a road vehicle battery (transportable Breath analysers). |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 during conditions where electrical surges are superimposed on the mains voltage specified at serial number (d) of Table 3 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the equipment under test to electrical surges for which the rise time, pulse width, peak values of the output voltage or current on high/low impedance load and the minimum time interval between two successive pulses are specified in the international standard IEC 61000-4-5 [25]. |
| | | (ii) A surge generator as defined in the international standard IEC 61000-4-5 [25] shall be used. The characteristics of thegenerator shall be verified before connecting the EUT. |
| | | (iii) The injection network circuit depends on the applicable conductor and is defined in the international standard IEC 61000-4-5 [25]. At least 3 positive and 3 negative surges shall be applied. |
| | | (iv) On AC mains supply lines, the surges shall be synchronised with the AC supply frequency and shall be repeated such that the injection of surges on all the 4 phase shifts: 0°, 90°, 180° and 270°with the mains phase is covered. |
| | | (v) The surges are applied during all the time necessary to perform the test, accordingly more surgesthan indicated above shall be necessary. |
| | | (vi) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Mains mode. | AC | DC |
| | | | Line to line | Line to ground | Line to line | Line to ground |
| | | 1.0 kV | 2.0 kV | 1.0 kV | 2.0 kV |
| | Number of Surges. | 3 positive | 3 positive | 3 positive | 3 positive |
| | | 3 negative | 3 negative | 3 negative | 3 negative |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in sub-paragraph (5). |
| | | (ii) Either significant faults do not occur, or checking facilities detect and act on potential significantfaults, thus preventing such faults from occurring. |
| | | (iii) It is acceptable that during the disturbance test the EUT may not provide a measurement result. |
(F) Bursts on signal, data and control lines:
Table 30 - Bursts (transients) on signal, data and control lines.
| Serial | Test method. | Introducing transients on signal, data and control lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to Breath analysers which while in operation are designed to be permanently or temporarily connected to external electrical signal, data or control lines. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (11) of paragraph 1 during conditions where electrical bursts are superimposed on I/O and communication ports specified at serial number (e) of Table 3 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to bursts of voltage spikes for which the output voltage on 50 Ω and 1000 Ω loads are specified in the international standard IEC 61000-4-4 [24]. |
| | | (ii) A burst generator as specified in the international standard IEC 61000-4-4 [24] shall be used and the characteristics of thegenerator shall be verified before connecting the EUT. |
| | | (iii) Both positive and negative polarities of the bursts shall be applied. |
| | | (iv)Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Amplitude (peak value) | 1 kV. |
| | Repetition rate | 5 kHz. |
| | Duration of the test | ≥1 min for each amplitude and polarity. |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv)Parameters at least to be recorded: |
| | | (a) as defined in clause (iii) of sub-paragraph (5) ;and |
| | | (b) exposed conductors. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur, or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
| | | (iii) It is acceptable that during the disturbance test the EUT does not provide a measurement result. |
(G) Ripple on DC mains power:
Table 31 — Ripple on DC mains power.
| Serial | Test method. | Introducing a ripple voltage on the DC input power port. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to those Breath analysers which are designed to be temporarily or permanently connected to a DC power network (distribution system) supplied by external rectifier systems while in operation. |
| | | (ii) Not applicable to: |
| | | (a) transportable Breath analysers powered by a road vehicle battery, and |
| | | (b) transportable Breath analysers connected to battery charger systems with incorporated switchmode converters. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (11) of paragraph 1 under conditions of a ripple on the DC mains voltage specified at serial number (f) of Table 3 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises subjecting the EUT to ripple voltages such as those generated by traditional rectifier systems or auxiliary service battery chargers overlaying on DC power supply sources. |
| | | (ii) A test generator as specified in the international standard IEC 61000-4-17 [28] shall be used and before starting the tests, the performance of the generator shall be verified. |
| | | (iii) The frequency of the ripple voltage is the applicable power frequency or a multiple (2, 3 or 6)dependent on the rectifier system used for the mains. |
| | | (iv) The waveform of the ripple at the output of the test generator has a sinusoidal-linear character. The test level is a peak-to-peak voltage expressed as a percentage of the nominal DC voltage UDC. |
| | | (v) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Percentage of the nominal DC voltage UDC | 2 % |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | Parameters to be recorded shall be as specified in clause (iii) of sub paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and fault of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur, or checking facilities detect and act on potentialsignificant faults preventing such faults from occurring. |
| | | (iii) During the disturbance test the EUT may not provide a measurement result. |
(H) DC mains voltage dips, short interruptions and (short term) variations:
Table 32 - DC mains voltage dips, short interruptions and (short term) variations.
| Serial | Test method. | Introducing voltage dips, short interruptions and voltage variations on DC mains power |
| Number | | lines using the test setup specified in the international standard IEC 61000-4-29 [30]. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to those Breath analysers which are designed to be temporarily or permanently connected to aDC mains power network while in operation. |
| | | (ii) Not applicable to transportable Breath analysers powered by a road vehicle battery and Breath analysers requiring a DC to AC conversion. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 under conditions of disturbances on the DC mains voltage specified at serial number (g) of Table 3 of clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) A test generator as specified in the international standard IEC 61000-4-29 [30] shall be used and before starting the tests, theperformance of the generator shall be verified. |
| | | (ii) The EUT shall be exposed to voltage dips, short interruptions, for each of the selected combinations of amplitude and duration, using a sequence of three dips/interruptions and intervals of at least 10 s between each test event. The EUT shall be tested for each of thespecified voltage variations. |
| | | (iii) The disturbances are applied during all the time necessary to perform the test, accordingly moredisturbances than indicated above shall be necessary. |
| | | (iv) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions) |
| | | (b) Measurements during disturbance |
| 5. | Test level. | Amplitude of the rated voltage | Duration |
| | Voltage dips | Test a | 40 % | 0.01 s |
| | | Test b | 1 s |
| | | Test c | 70 % | 0.01 s |
| | | Test d | 1 s |
| | Short interruptions | Test e | 0 % | 0.001 s |
| | | Test f | 1 s |
| | Voltage variations | Test g | 85 % | 0.1 s |
| | | Test h | 10 s |
| | | Test i | 120 % | 0.1 s |
| | | Test j | 10 s |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 of sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5 for each test condition. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph(5); and |
| | | (b) percentage of voltage reduction and duration. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5) of paragraph 6 of Part 2 for each testcondition. |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potential significant faults thereby preventing such faults from occurring. |
| | | (ii) During the disturbance test the EUT may not provide a measurement result. |
(I) AC mains voltage dips, short interruptions and voltage variations:
Table 33 - AC mains voltage dips, short interruptions and voltage variations:
| Serial | Test method. | Introducing short-time reductions of mains voltage using the test setup specified in the |
| Number | | international standards IEC 61000-4-11 [27], international standards IEC 61000-6-1 |
| | | [31] and international standards IEC 61000-6-2 [32]. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to those Breath analysers having a rated input current of less than 16 ampere per phase and that are designed to be temporarily or permanently connected to an AC mains power network while inoperation. |
| | | (ii) Not applicable to transportable Breath analysers powered by a road vehicle battery. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 under conditions of short time mains voltage reductions specified at serial number (g) under Table 3 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) A test generator is to be used which is suitable to reduce the amplitude of the AC mains voltage for the required period of time and the performance of the test generator shall be verified before connecting the EUT. |
| | | (ii) The mains voltage reduction tests shall be repeated 10 times with intervals of at least 10 s between the tests. |
| | | (iii) The tests shall be applied continuously during the measurement time. The fault of the EUT isdetermined separately for each of the different dips and reductions. |
| | | (iv) The interruptions and reductions are repeated throughout the time necessary to perform the whole test; for this reason, more than ten interruptions and reductions shall be necessary. |
| | | (v) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Amplitude | Duration |
| | Voltage dips | Test a | 0 % | 0.5 cycles |
| | | Test b | 0 % | 1 cycle |
| | | Test c | 70 % | 25 cycles |
| | Short interruptions | Test d | 0 % | 250 cycles. |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5 for each test condition. Time schedule: consecutively at each test condition. |
| | | (iii) Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5); and |
| | | (b) percentage of voltage reduction and duration. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5) for each testcondition. |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potential significant faults preventing such faults from occurring. |
| | | (iii) It is acceptable that during the disturbance test the EUT does not provide a measurement result. |
(J) Surges on signal, data and control lines:
Table 34 - Surges on signal, data and control lines.
| Serial | Test method. | Introducing electrical surges on signal, data and control lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to those Breath analysers which are designed, during operation, to be temporarily or permanently connected to electrical signal, data or control lines that shall exceed a length of 10 m. Not applicable to Breath analysers connected to a local power source through an indoor network. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (11) of paragraph 1 during conditions where electrical surges are superimposed on I/O and communication ports specified at serial number (h) of Table 3 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to electrical surges for which the rise time, pulse width, peak values of the output voltage/current on high/low impedance load and the minimum time interval between two successive pulses are specified in the international standard IEC 61000-4-5 [25]. |
| | | (ii) A surge generator as specified in the international standard IEC 61000-4-5 [25] shall be used. The characteristics of the generator shall be verified before connecting the EUT and at least 3 positive and 3 negative surges shall be applied. The applicable injection network depends on the kind of wiring the surge is coupled into and is specified in the international standard IEC 61000-4-5 [25]. |
| | | (iii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions) |
| | | (b) Measurements during disturbance |
| 5. | Test level. | Unsymmetrical lines | Symmetrical lines | Shielded I/O and |
| | | | | communication lines |
| | | Line to line | Line(s) to ground | Line(s) to ground | Shield to ground |
| | | 1.0 kV | 2.0 kV | 2.0 kV | 2.0 kV |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as defined. |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters at least to be recorded: |
| | | (a) as specified in clause (iii) of sub-paragraph (5); and |
| | | (b) exposed conductors. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph(5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults preventing such faults from occurring. |
| | | (iii) During the disturbance test the EUT may not provide a measurement result. |
(K) Electrical transient conduction along supply lines:
Table 35 - Electrical transient conduction along supply lines.
| Serial | Test method. | Electrical transient conduction along supply lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to portable and transportable Breath analysers which shall be in operation while being powered by an in-vehicle battery that is being charged by a combustion engine driven generator. |
| 2. | Object of the test. | (i) This test is applied to verify compliance of the EUT with the requirements in clause (i) of sub-paragraph (11) of paragraph 1 when exposed to electrical transients conducted along the power lines from an external DC power source where this power source concerns the on-board batteries of a vehicle (serial number (i) of Table 3 of clause (i) of the said sub-paragraph. |
| | | (ii) Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (1) of paragraph 1, under the followingconditions, namely:– |
| | | (a) transients due to a sudden interruption of currents in a device connected in parallel with the device under test due to the inductance of the wiring harness (pulse 2a); |
| | | (b) transients from DC motors acting as generators after the ignition is switched off (pulse 2b); |
| | | (c) transients on the supply lines which occur as a result of the switching processes (pulses 3a and 3b) specified at serial number (i) of Table 3 under clause (i) of sub paragraph (11) of paragraph 1. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to disturbances on the power voltage by directcoupling into the supply lines. |
| | | (ii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Test pulse | Pulse voltage Us |
| | | Unom = 12 V | Unom = 24 V |
| | 2a | 112 V | 112 V |
| | 2b | 10 V | 20 V |
| | 3a | –220 V | –300 V |
| | 3b | 150 V | 300 V |
| 6. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5 |
| | | (ii) Number of measurements (during disturbance): 5 |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potential significantfaults preventing such faults from occurring. |
| | | (iii) The EUT may not provide a measurement result during the disturbance test. |
(L) Electrical transient conduction via lines other than supply lines:
Table 36 - Electrical transient conduction via lines other than supply lines.
| Serial | Test method. | Electrical transient conduction along lines other than supply lines. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to I/O lines of transportable Breath analysers installed in vehicles. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 under conditions of transients which occur on other lines as a result of the switching processes (pulses a and b) (at serial number (j) of Table 3 of clause (i) of the said sub-paragraph). |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) The test consists of exposure of the EUT to bursts of voltage spikes by capacitive coupling via lines other than supply lines, using only the Capacitive Coupling Clamp method. |
| | | Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) Measurements during disturbance. |
| 5. | Test level. | Unom | 12 V | 24 V |
| | Pulse a | Us | –60 V | –80 V |
| | Pulse b | Us | 40 V | 80 V |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub clause (b) of clause (iii) of the said sub-paragraph (4). |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements (during disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters at least to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potential significantfaults preventing such faults from occurring. |
| | | (iii) During the disturbance test the EUT may not provide a measurement result. |
(M) Mechanical shock:
Table 37 - Mechanical shock.
| Serial | Test method. | Dropping the EUT onto a rigid surface. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 under conditions of mechanical shocks specified at serial number (a) of Table 4 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 4. | Test procedure in brief. | (i) For stationary or transportable Breath analysers: |
| | | (a) the EUT, standing in its normal position of use on a rigid surface, is tilted along one bottom edge and subsequently is allowed to fall freely back on to the test surface. The height of fall is the distance between the opposite bottom edge and the test surface. The angle between the bottom and the test surface shall not exceed 30°. |
| | | (ii) For portable Breath analysers: |
| | | (a) the test surface shall be smooth, hard, rigid, horizontal and made of concrete or steel; |
| | | (b) the specimen shall be allowed to fall freely in its normal attitudes of use taking into account all 3 spatial axes; |
| | | (c) the height shall be measured from the part of the specimen nearest to the test surface whenthe specimen is suspended prior to letting it fall. |
| | | (iii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) The disturbance shall be applied; |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | Stationary Breath analysers. | Transportable Breath analysers. | Portable Breath analysers |
| | Height of fall | 25 mm | 50 mm | 1000 mm |
| | Number of falls (on each bottom edge) | 1 | 1 | 6 |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (ii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements at reference conditions (after disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters at least to be recorded: as defined in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and fault of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
(N) Shakes:
Table 38 - Shakes.
| Serial | Test method. | Exposure to shakes while not in operation. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to portable and transportable Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub paragraph (11) of paragraph 1 after being exposed to shakes likely to be experienced in a car boot and specified at serial number (b) of Table 4 of clause (i) of the said sub paragraph. |
| 3. | Condition of the EUT. | (i) Power is to be ―off‖ for the duration of the test. |
| | | (ii) The EUT is mounted in its reference position on a table which shall generate shakes and is kept in switched off mode during the exposure to the influence quantity, it shall be switched onimmediately after this exposure. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to simulated shakes fulfilling the specified test level. After the exposure, the external electrical power (where applicable) shall be connected and the EUT shall be switched on following which the EUT performance is tested. |
| | | (ii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) The disturbance shall be applied; |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | (i) Shakes specifications: |
| | | (a) wave shape: half—period of a sinusoid; |
| | | (b) amplitude: 10 g (g =9.81 m/s2); |
| | | (c) duration: 6 ms; |
| | | (d) frequency: 2 Hz; |
| | | (e) number of axes: 3 perpendicular axes; |
| | | (f) number of shakes: 1000 for each axis. |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii)Number of measurements at reference conditions (after disturbance): 5. |
| | | (iii) Time schedule: consecutively at each test condition. |
| | | (iv) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause(iv) of sub-paragraph (5) |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potential significant faults preventing such faults from occurring. |
(O) Damp heat cyclic (condensing):
Table 39 - Damp heat, cyclic (condensing).
| Serial | Test method. | Exposure to damp heat with cyclic temperature variation. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to transportable and portable Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (11) of paragraph 1 under conditions of high humidity combined with cyclic temperature changes specified at serial number (c) of Table 4 of clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | (i) Power is to be ―off‖ for the duration of the test. |
| | | (ii) Before and after the disturbance, the electrical power is supplied to the EUT and switched on for a time period of at least the warm-up time specified by the manufacturer. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to cyclic temperature variations between 25 °C and the appropriate upper temperature while maintaining the relative humidity above 95 % during the temperature change and the low temperature phases and at or above 93 % RH at the upper temperature phases. |
| | | (ii) Condensation is expected to occur on the EUT during the temperature rise.The 24 hour cycle comprises of: |
| | | (a) temperature rise for 3 hours; |
| | | (b) temperature maintained at the upper value until 12 hours from the start of the cycle; |
| | | (c) temperature lowered to the lower temperature level within a period of time of 3 to 6 hours, the declination (rate of fall) during the first hour and a half being such that the lower temperature level would be reached in a 3—hour period; |
| | | (d) temperature maintained at the lower level until the 24 hour period is completed. |
| | | (iii) The stabilising period before and the recovery period after the cyclic exposure shall be such that the temperature of all parts of the EUT is within 3 °C of its final value. |
| | | (iv) Special electrical conditions and recovery conditions shall need to be specified. |
| | | (v)Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) The disturbance shall be applied; |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | Upper temperature. | 55 °C |
| | Relative humidity at upper temperature. | ≥93 % |
| | | Transportable Breath analysers | Portable Breath analysers |
| | Duration (number of 24-hour cycles). | 2 | 4 |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions:temperature and humidity at the respective test level, all other parameters within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements at reference conditions (after disturbance): 5. |
| | | (iii) Time schedule: consecutively before and after exposure, after switching on the EUTand after a one-hour recovery period at reference conditions. |
| | | (iv) Parameters to be recorded shall be as defined in clause (iii) of sub paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
(Q) Vibration (as disturbance):
Table 41 - Vibration (as disturbance).
| Serial | Test method. | Exposure to random vibration. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to stationary Breath analysers. |
| 2. | Object of the test. | Verification of compliance with the provisions for disturbances in clause (i) of sub-paragraph (11) of paragraph 1 after being exposed to the extreme situations which shall occur during transport of the instrument as specified at serial number (e) of Table 4 under clause (i) of the said sub-paragraph. |
| 3. | Condition of the EUT. | (i) Power is to be ―off‖ for the duration of the test. |
| | | (ii) The EUT shall be switched on immediately after this exposure. |
| 4. | Test procedure in brief. | (i) The EUT shall subsequently be tested in three mutually perpendicular axes mounted on a rigidfixture by its normal mounting means. |
| | | (ii) The EUT shall normally be mounted in such a way that the gravity vector points in the samedirection as it would in normal use. |
| | | (iii) If the measurement principle is such that the effect of the direction of the gravity vector shall beconsidered negligible, the EUT shall be mounted in any position. |
| | | (iii) After the exposure, the external electrical power (where applicable) shall be connected and the EUT shall be switched on. Then, the EUT performance is tested. |
| | | (iv) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) The disturbance shall be applied; |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | Total frequency range | 10 Hz – 150 Hz |
| | Total RMS level | 1.6 m·s—2 |
| | ASD level 10 Hz – 20 Hz | 0.05 m2·s—3 |
| | ASD level 20 Hz – 150 Hz | -3 dB/octave |
| | Duration per axis | For each of the orthogonal directions the vibration exposure time shall be at least 2 minutes. |
| 6. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before disturbance): 5. |
| | | (ii) Number of measurements at reference conditions (after disturbance): 5. |
| | | (iii) Time schedule: test consecutively after switching on the EUT and after the warm-up period of the equipment under test at reference condition. |
| | | (iv) Parameters to be recorded: as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) The errors and fault of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
(r) Durability,— The instrument shall be presumed to comply with the requirement specified in sub-paragraph (5) of paragraph 1, if the instrument submittedto the accuracy tests and disturbance tests passes each of the tests.
(ix) Physiological influence substances:
Table 42 - Physiological influence substances:
| Serial | Test method. | Test gases with additionally one interfering substance at a time. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers. |
| 2. | Objective of the test. | Verification of compliance with the provisions in clause (ii) of sub-paragraph (11) of paragraph. |
| 3. | Condition of the EUT. | The EUT electrical power shall be switched on during the test. |
| 4. | Test procedure in brief. | (i) The test comprises of at least 5 measurements per test gas. |
| | | (ii) Test sequence: |
| | | (a) Measurement with test gas number 4 |
| | | (b) Measurement with test gas number 4 with one additional substance. For each substance, this test sequence shall be repeated 4 times. |
| 5. | Test gases | (a) Ethanol concentration: 0.40 mg/L (test gas no. 4) |
| | | (b) 0.40 mg/L ethanol plus acetone: 0.5 mg/L |
| | | (c) 0.40 mg/L ethanol plus methanol: 0.1 mg/L |
| | | (d) 0.40 mg/L ethanol plus isopropanol: 0.1 mg/L |
| | | (e) 0.40 mg/L ethanol plus carbon monoxide: 0.2 mg/L |
| | | Depending on the results, additionally test gases with reduced concentration of the interferingsubstances shall be needed (see acceptance criteria). |
| 6. | Measurement conditions. | (i) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements with each test gas and concentration: 5. |
| | | (ii) The parameters specified in clause (iii) of sub-paragraph (5) shall be recorded. |
| 8. | Calculation of results. | (i) Calculation of deviation: |
| | | the deviation is [1…5] between each result of the 5 measurements with the respective interfering substance (b) to (e) and the appendant result for ethanol test gas (a) is calculated (stated at serial number 5). |
| | | (ii) Calculation of sensitivity: |
| | | sensitivityis = Δ(ρi−1, i) / mass concentration of interfering substance |
| 9. | Acceptance criteria. | (i) If none of the calculated values for sensitivity is equal or below the value specified in clause (ii) of sub-paragraph (11) of paragraph 1 the breath analyser has passed the test for the interference substance concerned; |
| | | (a) if a calculated value for sensitivity exceeds the value specified in clause (ii) of sub-paragraph (11) of paragraph 1 and no error message is given, the breath analyser has failed; |
| | | (b) if an error message is displayed, another sequence of 5 tests shall be performed with the same interfering substance at a mass concentration 5 times lower. In this case the sensitivity shall not be more than the value specified in clause (ii) of sub-paragraph (11) of paragraph 1; |
| | | (c) if an error message continues to be displayed, the mass concentration of the added interfering substance shall be reduced repeatedly by a factor of 2 and again, another sequence of 5 tests shall be performed. If the error message is no longer displayed and the sensitivity is not more than the value specified in clause (ii) of sub-paragraph (11) of paragraph 1 the breath analyser has passed the test for the interference substance concerned. |
| | | (d) This requirement shall be fulfilled for each measurement with each interfering substance. |
(6) Tests for optional disturbances and requirements:
(i) Sand and dust:
Table 43 - Sand and dust.
| Serial | Test method. | Exposure to sand and dust. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to Breath analysers expected to be used in a dusty or sandy environment. |
| 2. | Objective of the test. | Verification of compliance with the provisions in clause (iii) of sub-paragraph (11) of paragraph 1 under a sand or dust-laden atmosphere. |
| 3. | Condition of the EUT. | The EUT electrical power shall be switched off during the test. |
| 4. | Test procedure in brief. | (i) The test comprises of exposure of the EUT to cyclic temperature variation between 30 °C and65 °C, maintaining the following conditions: |
| | | (a) Relative humidity: less than 25 %, |
| | | (b) Air velocity: 3 m/s, |
| | | (c) Particle concentration: 5 g/m3, |
| | | (d) Composition of the particles. |
| | | (ii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions); |
| | | (b) The disturbance shall be applied; |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | Number of test cycles. | One |
| | Cycle duration. | 2 hours |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions before exposure: 5. |
| | | (ii) Number of measurements at reference conditions after exposure: 5. |
| | | (iii) The parameters specified in clause (iii) of sub-paragraph (5) shall be recorded. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur, or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
(ii) Salt mist:
Table 44 — Salt mist.
| Serial | Test method | Exposure to salt mist. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable when the measuring instrument is expected to be used in a humid salty environment. |
| 2. | Objective of the test. | Verification of compliance with the provisions in clause (iii) of sub-paragraph (11) of paragraph 1 under salt mist atmosphere. |
| 3. | Condition of the EUT. | The EUT electrical power shall be switched off during the test. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to salt mist atmosphere at the following conditions: |
| | | (a) Temperature of environment and salt solution: 35 °C, |
| | | (b) Mass fraction of NaCl of the salt solution: (5 ± 1) %, |
| | | (c) Relative humidity of the test atmosphere: > 85 %, |
| | | (d) Salt solution to be nebulized to such an amount that it will condense with a rate of1 to 2 ml/ hour per surface of 80 cm2. |
| | | (ii) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions), |
| | | (b) The disturbance shall be applied, |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Duration of the test. | 24 hours. |
| 6. | Measurement conditions. | (i) Ethanol concentration:0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub-paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions before exposure: 5. |
| | | (ii) Number of measurements at reference conditions after exposure: 5. |
| | | (iii) The parameters specified in clause (iii) of sub-paragraph (5) of paragraph 6 shall be recorded. |
| 8. | Acceptance criteria. | (i) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (ii) Either significant faults do not occur or checking facilities detect and act on potentialsignificant faults thereby preventing such faults from occurring. |
(iii) Water:
Table 45 – Water.
| Serial | Test method. | Exposure to water droplets. |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to portable Breath analysers expected to be used in outdoor conditions or on boats. |
| 2. | Object of the test. | Verification of compliance with the provisions in clause (iii) of sub-paragraph (11) of paragraph 1 under wet weather conditions. |
| 3. | Condition of the EUT. | (i) Power is to be ―on‖ for the duration of the test. |
| | | (ii) The test shall be performed according to the manufacturer‘s prescriptions (with the mouthpiece mounted on the breath analyser, with a protective cover). The measurements shall be performed before and after exposure. The mouthpiece shall be changed before the measurement. |
| 4. | Test procedure in brief. | (i) The test comprises exposure of the EUT to water droplets in specified angles: |
| | | (a) Temperature of the water shall be equal to the temperature of the EUT within ± 5 °C; |
| | | (b) Water quality: potable water. |
| | | (ii) During the test, the moisture contained inside the enclosure shall partly condense. The dewwhich shall thus deposit shall not be mistaken for an ingress of water. |
| | | (iii) The EUT is placed in its normal operating position under the drip box or spray nozzle. Except for EUTs designed for wall mounting, the support for the EUT shall be smaller than the baseof the enclosure. |
| | | (iv) Test sequence: |
| | | (a) Measurements before disturbance (at reference conditions), |
| | | (b) The disturbance shall be applied, |
| | | (c) Measurements after disturbance (at reference conditions). |
| 5. | Test level. | Test level index | 2 |
| | Test condition | Spraying water within an angle up to 180° from vertical. |
| | Test equipment | Oscillating tube | Spray nozzles |
| | Position of EUT | EUT at the centre of the oscillating tube | EUT on turntable |
| | Water flow rate. | (0.07 ± 0.0035) L/min per hole | (10 ± 0.5) L/min |
| | Test duration. | 10 min per position | 1 min/m2 of EUT |
| | Angel of inclination. | 180 ° | |
| 6. | Measurement conditions. | (i) Ethanol concentration: 0.40 mg/L (test gas no. 4). |
| | | (ii) Test gas conditions: within reference gas conditions as specified in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) and in Table 6 under sub-clause (b) of clause (iii) of the said paragraph . |
| | | (iii) Ambient conditions: within reference conditions as specified in clause (i) of sub paragraph (4). |
| 7. | EUT performance. | (i) Number of measurements at reference conditions (before exposure): 5. |
| | | (ii) Number of measurements at reference conditions (after exposure): 5. |
| | | (iii) Time schedule: after drying externally the EUT by wiping or by applying low velocityforced air at room temperature, consecutively at each test condition. |
| | | (iv) Parameters to be recorded as specified in clause (iii) of sub-paragraph (5). |
| 8. | Acceptance criteria. | (i) Water shall have no harmful effects. |
| | | (ii) The errors and faults of the EUT shall be determined as prescribed in clause (iv) of sub-paragraph (5). |
| | | (iii) Either significant faults do not occur or checking facilities detect and act on potential significant faults thereby preventing such faults from occurring. |
7. Verification and re-verifications (Initial and subsequent verifications).— (1) General considerations: Individual Breath analysers within the scope of this specification shall require initial verification when newly produced according to the approved type and shall require re-verification when in service.
(i) Verification:
The initial verification of each individual instrument is intended to verify that the EBA is correctly adjusted and conforms to the approved type. The verification shall be carried out using standard equipment, having adequate accuracy. These standards shall be subjected to a suitable calibration program, assuring their traceability. The tests for initial verifications shall be carried out on the complete instrument.
(ii) Re verification: Re verification is the verification of a measuring instrumentafter a previous verification and includes mandatory periodic verification and verification after repair.
(2) Status of the instrument submitted for verification: All Breath analysers produced and ready for initial verification or re-verification shall conform to the approved type. Initial verification of a breath analyser includes a procedure to ensure that the individual measuring instrument conforms to the approved type. Notwithstanding this initial verification, the manufacturer has the full responsibility that the instrument complies with all the applicable requirements according to this specification and other requirements.
(3) Visual examination: Before starting the practical tests, the following examinations shall be performed, namely:-
(i) a visual inspection to determine the conformity with the approved type and to obtain a general appraisal of its design and construction;
(ii) completeness of essential accessories and subsidiary devices (for example mouthpieces, durable storage or printing device) and their compliance with the approved type;
(iii) compliance of the software with the approved type;
(iv) completeness and correctness of the inscriptions and markings;
(v) presence, completeness and language of the documentation intended for the user;
(vi) type of paper and ink (if applicable);
(vii) information for the positioning of sealing and stamping; and
(viii) correct date and time settings, within allowed tolerance.
Note: It is assumed that with a specific software version (which shall be mentioned in the type approval) all measuring conditions such as the measuring range, unit, resolution in different modes, presentation of the result, details of the measurement cycle and fraud protection are also predetermined. If the measuring range, the unit of the result, or the presentation of the result are not predetermined in the software, it shall be stated in the type approval certificate and the setting of this parameter shall also be inspected.
(4) Metrological examination:
(i) Metrological precondition for performing tests: The performance tests shall be executed under reference conditions unless specified otherwise within the test. Before starting the tests, it shall be verified that the EBA is switched on for the time period necessary for warm-up.
(ii) Test gases used for verification: The gas used for verification shall comply with the requirements of sub-clause (a) of clause (iii) of sub-paragraph (4) (Table 4). The simplified means (as those specified in sub-clause (b) of clause (iii) of the said sub-paragraph) shall be used.
If the use of simplified means is prescribed, the requirements of sub-clause (b) of clause (iii) of sub-paragraph (4) of paragraph 6 and sub-clause (c) of clause (iii) of the said sub-paragraph shall be taken into account. Verification reports shall indicate when other gases were used and how their equivalence with the reference gases was established.
(iii) Tests for initial or re verifications: The following minimum test program applies to the verification of all Breath analysers.The verification shall include –
a metrological examination of the breath analyser; and
(b) visual examination for conformity of the breath analyser.
(a) Metrological examination: The following metrological examination tests shall be carried out on every EBA due forverification, namely:–
Accuracy tests: at least three different concentrations shall be tested, with minimum 3 repetitions at eachconcentration.
Different approaches shall be used, such as for example:
the complete measuring range shall be tested for accuracy; at least 3 different test gasconcentrations are recommended;
only part of the measuring range close to the allowed limit(s) shall be tested for accuracy.
Each measurement result shall fulfil the maximum permissible errors of clause (i) of sub-paragraph (6) of paragraph 1 or clause (ii) of the said sub-paragraph.
Additional tests shall be carried out with different volumes (for example 1.5 L, 4.5 L), exhalation times (for example 15 s), flow rates or with a greater number of repetitions. Results from these tests shall also comply with the maximum permissible errors.
Metrological examinations shall assure that all parameters of the EBA which shall have an influence on the result are set correctly. Depending on the actual configuration of the EBA, additionaltests for checking internal sensors such as pressure or temperature sensors shall be mandatory.
(b) Verification marks, seals and documentation: After successful verification, the verification marks and seals shall be attached and an accompanying document shall be produced.
ANNEXURE A
GENERAL EXAMPLES FOR TEST GAS GENERATORS
(Informative)
1. Reference principle for the implementation of the test.— For the production of wet test gases based on the principles of Henry‘s law, the ethanol concentration in thegas phase shall be calculated with one of the following equations:
(1) Dubowski‘s formula:
Let ϒ(t) be the mass concentration of ethanol of an aqueous solution of ethanol. When air is bubbled through such a solution, the mass concentration (t) of ethanol in the produced test gasis given by the following formula:
β(t) = 0.04145 × 10—3 × ϒ(t) × e(0.06583×t)
with: (t) mass concentration of ethanol in the test gas at a given temperature t in mg/L0.04145 × 10—3 and 0.06583 conventional Dubowski coefficients
ϒ(t) mass concentration of ethanol in the aqueous solution at a given temperature in mg/L
t temperature of solution and test gas in °C
For t = 34 °C the equation shall be simplified to:
β(34) = 0.38866 × 10—3 xγ(34)
(2) Harger‘s formula:
The conventional partition ratio for the concentration of ethanol in gas to the concentration of ethanol inaqueous solution at a temperature of 34 °C is given by:
Ka/w = 0.000393
This leads to
β(34) = 0.38866 × 10—3 xγ(34)
at a temperature of t = 340C
2. Example of a type 1 test gas generator.—(i) The saturation of air with water vapour and ethanol vapour when lead through a water-ethanol solution shall be used for a wet test gas generator for breath analysers.
(ii) They are based on the principle of Henry‘s law, applied on dissolved substances in aqueous solutions.
(iii) In equilibrium conditions, the partition ratio of the concentration of a species in the liquid phase and in the gas phase shall be constant. For dilute aqueous solutions, this partition ratio shall be assumed as only temperature dependent.
(iv) For the partition ratio for ethanol at several temperatures, various empiric data shall be found in the literature.
(v) For breath alcohol analysis, the equations given in A.1 shall be used for the calculation of the gas concentration of ethanol for a given temperature.
(vi) An example of a type 1 test gas generator is the bubble train.
(vii) In principle, the bubble train consists of a number of gas washing flasks connected in series, within a temperature controlled environment, for example a temperature-controlled bath. The flasks shall be filled with the water-ethanol solution of a known concentration and pressurised air or gas passing through the solution in smallbubbles will be heated up as well as enriched with ethanol and water in a dynamic equilibrium. Figure A.1 shows a basic design principle for a 3-flask-bubble train.
[Image: Figure A.1 - Diagram of a 3-flask-bubble train as a type 1 test gas generator, with labels: pressurised air, wet test gas, Temperature controlled bath, gas washing flasks with water—ethanol solution]
(viii) During the process of bubbling gas through the ethanol-water solution, a portion of the ethanol shall be carried away by the gas flow. This results in a continuous decrease in ethanol concentration within both the solution and the test gas, in direct proportion to the volume of gas passed through. This effect shall be taken into account during the preparation and execution of tests.
(ix) To minimize the depletion of ethanol concentration and ensure consistency, a minimum of two gas-washing flasks shall be connected in series. These additional flasks shall function as buffer stages, stabilizing the ethanol concentration in the test gas over a specified test volume.
(x) The evolution of ethanol concentration in the solution as a function of the produced gas volume shall follow the qualitative model shown in Figure A.2. Compliance with this concentration trend is required for accurate and repeatable measurements.
[Image: Figure A.2 - Example of the evolution of the gas concentrations in a 3-flask-bubble train, showing decrease of ethanol concentration curves for 1st, 2nd, 3rd flasks]
(xi) A series configuration comprising at least two bubble flasks shall be used to achieve a stable mass concentration of ethanol at the outlet for a defined volume of test gas. This setup shall allow for multiple consistent measurements. The use of two or more bubble train systems to facilitate efficient and effective testing schemes shall be helpful.
(xii) The temperature of the ethanol-water solution bath shall be maintained at a constant value throughout the test as the partition equilibrium is temperature-dependent. Temperature stability is mandatory and appropriate temperature corrections shall be applied to ensure the accuracy of the test gas concentration.
(xiii) In accordance with Henry‘s law, the ethanol concentration in the test gas shall be adjusted by:
(a) changing the concentration of the ethanol-water solution in the flasks, or
(b) varying the temperature of the ethanol-water solution.
Note 1: When generating test gases with different ethanol concentrations at a constant temperature (for example 34.0 °C) distinct ethanol-water solutions with corresponding concentrations shall be used.
Note 2: Compression of the wet test gas after exiting the bubble train shall be strictly avoided. Any flow restrictions-such as a narrow outlet-that could cause back pressure or alter the gas characteristics before the gas enters the EBA under test shall be eliminated.
3. Example of a type 2 test gas generator: (i) The test gas generator shall be capable of producing a stable gas mixture with varying concentrations of ethanol. The generated gas mixture shall simulate human breath profiles and shall conform to the specifications outlined in clause (iii) of sub-paragraph (4) of paragraph 6 of Part 2.
(ii) The generation of the ethanol gas mixture shall be controlled by gas and liquid mass flow controllers, which shall be managed by an integrated gas analyser. The composition and characteristics of the gas mixture shall be fully adjustable and controllable.
(iii) The dynamics of human breath profiles, including volumes and expiration durations, shall be simulated accurately. The simulation shall include the modelling of anatomical dead space. The injection volume and duration, representing simulated exhalation shall be regulated by an actuator system.
(iv) The ethanol concentration in each simulated breath shall be determined using an analysis system equipped with a Flame Ionisation Detector. This system shall operate independently of any technology employed in the breath analyser under test.
(v) A variable volume compartment shall be incorporated into the gas flow pathway after mixing. This compartment shall function as a mechanical dead volume and is essential for replicating the exponential development of ethanol mass concentration during exhalation. The ability to vary the dead volume shall enable modification of the gas concentration profile to match various exhalation curve shapes.
The gas analyser integrated within the system shall, depending on the technical implementation and particularly the flow control devices used, function as a verification instrument for the test apparatus. In the latter case, it shall be subject to regular calibration.
[Image: Figure A.3 - Example of a type 2 test gas generator, showing various components like standard gas, ethanol tank, water tank, air, CO2, mixing valve, mass flow controller, FID analyser, actuator, etc.]
Legend for Figure A.3.
Controlled evaporator mixer (CEM)
Valve
Water and alcohol tanks
Mass flow controllers (MFCs) (RDMs)
Mixing valve
FID analyser
Actuator
4. General information about breath profiles.- (i) The purpose of this specification is to evaluate the suitability of breath analysers for measuring the mass concentration of alcohol in exhaled human breath. The reproducibility is, influenced by the wide variability in human breath samples themselves.
(ii) The characteristics of a breath sample shall depend on the subject‘s willingness or physical capability or both to provide an optimal exhalation. Subjects may deliver samples via either a prolonged, steady exhalation or a brief, forceful one. Paragraph 4 of Annexure A shall be applied to define and characterise breath profiles and to establish standardised methods for simulating these profiles during testing.
(1) Example of human breath profiles,-
The forced exhalation of a human being is characterised by the flow of breath and the change of the concentration of the alcohol during exhalation.
(i) Flow profile,-
The flow profile of a forced exhalation is divided into three distinct areas:
the first part (located in the first ¼ of the time of exhalation) represents the peak of the flow at the timeof the exhalation;
the second Part is either a stable or a decreasing flow of breath, depending on the subject;
the third Part is a fast decrease of the flow when the subject terminates the exhalation.
The absolute flow rate achieved during an exhalation varies depending on the subject and the flow resistanceof the breath analyser.
[Image: Figure A.4 - Example of a flow profile of a human being, showing flow rate (L/min) vs. time (s)]
(ii) Alcohol concentration profile,-
(a) The alcohol concentration profile during a forced exhalation shall be characterised by an initial short delay in the rise of concentration followed by a steep increase. Thereafter, the rate of increase shall gradually diminish resulting in a nearly constant concentration toward the end of exhalation, referred to as the ―plateau‖ phase.
(b) The duration and characteristics of the alcohol concentration plateau in human breath shall vary depending on the individual morphology of the subject‘s respiratory system. This variation shall be recognised as a significant factor influencing the accurate determination of alcohol concentration.
(c) As the progression of alcohol concentration in a forced exhalation is dependent on the total exhaled volume, a representative volumetric expirogram of breath alcohol concentration shall be used to illustrate this relationship. The figure A.5 depicting this expirogram shall serve as a reference for test simulation and evaluation.
[Image: Figure A.5 - Example of a volumetric expirogram of breath alcohol concentration, showing BAC (mg/L) vs. Exhaled volume (L)]
(2) Simulation of breath profiles with test gas generators,-
(i) The characteristics of the breath profiles needed for the tests in Part 2 of this Specification are selected to correspond with the variability of real human breath profiles.
(ii) A type 2 test gas generator shall be able to perform the following simulations:
(a) Simulation curves of forced exhalation (exhalation profiles),- The simulated curves shall cover the characteristic variation of the air flow as a function of time during an exhalation of a human being.
(b) Simulation curves of alcohol concentration as a function of time (alcohol profiles),- The simulated curves shall cover the characteristic evolution of the alcohol plateau during an exhalation, taking into account the variations deriving from the diversity of human beings. The generated alcohol profiles shall have a steep increase and a real plateau of alcohol at the end ofthe injection of the test gas. This plateau shall have very small variations to avoid unnecessaryuncertainties in the test gas concentrations applied to the instrument under test.
(iii) Simulated exhalation profiles,- Figure A. 6 shows the flow profile as needed for the tests defined in sub clause (c) & sub-clause (c) of clause (vi) of sub paragraph (5) of paragraph 6:
(a) initial condition: 3 L; exhalation time; 5 s; flowrate: 0.6L/s;
(b) after 1.5 s, the flowrate decreases to 0.2 L/s;
(c) after 5 s, the flowrate remains equal to 0.2 L/s until the end of the exhalation.
[Image: Figure A. 6 - Simulated flow profile, showing flow rate (L/s) vs exhalation time (s)]
(iv) Simulated alcohol concentration profiles:
(a) Theoretical calculations taking into account the reduced exchange in the upper respiratory system of a human being (dead volume), shall be used to generate simplified, ideal exhalation profiles.
(b) The plateau is defined as the time at which the alcohol concentration is stabilised to at least 99 % of the reference value.
(c) For the calculation of the simulated progression of an alcohol concentration profile, the equation below shall beused.
(d) The dead anatomical volume shall be assumed as approximately 2.2 mL per kg of body mass, which leads to an average volume of 150 mL (68 kg × 2).
(e) With this assumed value of 150 mL, an ideal curve of the alcohol concentration (expressed in %) according to time and volume of the breath shall be calculated:
βi = βi−1 + [ D * (100 - βi−1) * (ti − ti−1) ] / Vm
where β = alcohol concentration (expressed in % of the reference value);
β0 = 0;
i = incremental index;
D = flowrate in L/s;
t = time of exhalation in s;
Vm = dead anatomical volume in L.
An example of a curve of alcohol concentration, calculated with this equation, is shown in Figure A.7 as afunction of time obtained on a simulation test bench.
[Image: Figure A.7 - Example of a calculated alcohol concentration profile, showing alcohol concentration in % vs exhalation time in s]
In practice, the alcohol concentration profile generated by the test gas generators shall look similar to thesimulated exhalation profile in Figure A.7.
ANNEXURE B
EXAMPLES OF DETECTION OF ALCOHOL IN UPPER RESPIRATORY TRACTS
(i) The presence of elevated alcohol concentration in the upper respiratory tract, commonly referred to as residual mouth alcohol shall be recognised as a phenomenon that occurs shortly after the consumption of substances containing alcohol. These substances shall include, but are not limited to, alcoholic beverages, food items, medicinal products and mouthwashes that contain alcohol.
(ii) Residual mouth alcohol shall be considered a transient condition. Under normal physiological circumstances, alcohol present in the upper respiratory tract shall dissipate and become undetectable after a short duration.
(iii) Breath samples collected during the presence of residual mouth alcohol shall exhibit a concentration profile characterised by an initial peak of high ethanol concentration followed by a rapid decay. This profile shall be taken into account during the evaluation of breath analyser performance.
(iv) Test procedures to assess the impact of residual mouth alcohol on measurement accuracy shall be conducted in accordance with the methods described in the following paragraphs:
1. Peak method.-
(1) Principle of the peak method:
The peak method is applicable only to Breath analysers which constantly monitor the ethanol concentration during the injection of the breath sample. The resulting ethanol profile shall be used for the detection of alcohol in the upper respiratory tracts.
For testing this kind of detection method for alcohol in the upper respiratory tracts, a test gas is needed which provides a profile of the ethanol concentration as indicated in Figure B.1.
[Image: Figure B.1 - Example of a simulated alcohol concentration profile with residual mouth alcohol, showing C (mg/L) vs Time (s), with a Maximum and Plateau region]
(t g α)max = -0.1 mg L—1 s—1 (± 0.01 mg L—1 s—1)
Such a test gas shall be generated for example by leading clean air through a balloon (two-neck round bottom flask) with a volume of approximately 500 ml. The balloon flask contains 250 ml of a water-ethanol solution with an ethanol concentration of 1.8 g/L, kept at a temperature of 34 °C. The clean air led through the balloon does not enter the water phase but will purge away the cloud of ethanol and water vapour, creating a peak of ethanol as required (see Figure B.1).
[Image: Figure B.2 - Example of a test balloon flask for creating concentration peaks, with labels: Clean air, Test gas, 34 °C, 1.8 g/L, 250 mL, Balloon volume: 500 mL]
(2) Test procedure for the peak method:
Table B.1 - Peak method
| Serial | Test method. | Measurements with a test gas with a peak in the ethanol concentration |
| Number | | profile. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | (i) Applicable to all Breath analysers with an ethanol sensor able to monitor the evolution of ethanol concentration during the sampling period. |
| 2. | Object of the test. | (i) Verification of compliance with the provisions in clause (viii) of sub paragraph (1) of paragraph 2 of Part 2 under ambient reference conditions. |
| 3. | Precondition. | As defined in clause (ii) of sub-paragraph (5) of paragraph 6 of Part 2. |
| 4. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 5. | Test procedure in brief. | The test comprises 5 measurements with the special test gas. |
| 6. | Measurement conditions. | (i) Test gas generator: |
| | | (a) type 2 (enhanced) or example given in Figure B.2. |
| | | (b) variation of the alcohol concentration as a function of time according to the evolution shown in Figure B.1. |
| | | (ii) Ethanol concentration: |
| | | Concentration profile as described in sub-paragraph (1) of paragraph 1 of this Annexure. |
| | | (iii) Test gas conditions: |
| | | (a) delivered volume: 3 L ± 0.1 L |
| | | (b) duration of injection: 15 s ± 0.5 s |
| | | (c) all other parameters as defined in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) of paragraph 6 of Part 2 and in Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iv) Ambient conditions: |
| | | (a) within reference conditions as defined in clause (i) of sub-paragraph (4) of paragraph 6 of Part 2. |
| 7. | EUT performance. | (i) Number of measurements per test scheme: at least 5. |
| | | (ii) Time schedule: to be performed consecutively for each test scheme. |
| | | (iii) Parameters at least to be recorded: as defined in clause (iii) of sub paragraph (5) of paragraph 6 of Part 2. |
| 8. | Acceptance criteria. | (i) The EUT shall detect the presence of alcohol in the upper respiratory tracts and shall cancel the measurement cycle. |
| | | (ii) It shall not deliver any measurement result and shall display an appropriate error message. |
2. Two-measurement cycle - first and second methods.-
(i) It is recognized that the presence of alcohol in the upper respiratory tract constitutes a short-term phenomenon. Accordingly, the results of two independent breath measurements, if performed within a short interval of time, may differ significantly due to the temporary nature of such alcohol presence.
(ii) In order to ensure adequate sensitivity for the comparison of results obtained during a two-measurement cycle, every breath analyser used for evidential purposes shall internally process and evaluate the measured alcohol concentration values using a scale interval not exceeding 0.001 mg/L.
(iii) Notwithstanding the internal processing requirements, the final result displayed and where applicable, printed by the breath analyser in the measuring mode shall be indicated with a scale interval of 0.01 mg/L.
(iv) Different technical and analytical approaches may be applied for the detection and evaluation of alcohol present in the upper respiratory tract. The breath analyser shall incorporate appropriate methodologies to account for such variations in the context of evidential breath analysis.
(1) Principle of the two-measurement cycle - first method:
(i) The measurement cycle of the EBA shall include two measurements of separate breath samples. The time delay between these two measurements shall be at least 2 minutes.
(ii) The EBA shall be equipped with the capability to store and retain an applicable allowed limit, which refers to the threshold value of breath alcohol concentration that constitutes a legal violation.
(iii) During a measurement cycle, the following incidents shall occur:
(a) result of the first measurement is less than the allowed limit:
(I) the measurement cycle shall automatically terminate after the first measurement. The result shall be displayed and printed, where applicable.
(II) In cases where the second measurement is not performed, the result of the first measurement shall be treated as an indicative result only. The system shall clearly indicate that the ―measurement cycle not completed‖.
(b) result of the second measurement is less than the allowed limit:
If one of the two measurement results are less than the allowed limit and the other is greater than or equal to the allowed limit, it shall be defined that the smallest result shall be displayed and printed. In this case, a comparison between the two results is not necessary.
(c) The results of both measurements are greater than or equal to the allowed limit:
(I) If both of the two measurement results are greater than or equal to the allowed limit, then it is necessary to calculate the ratio:
R = | 1 - β2/β1 | / t
With:
R Ratio to judge the change between first and second results.
t Time delay, in minutes, between the end of the first breath sample and the end of the secondbreath sample.
β1 Result of the measurement of the first breath sample.
β2 Result of the measurement of the second breath sample.
(II) Actions to be taken following the measurement depend on the ratio R:
(A) Case 1: if R is less than 0.03 min-1, alcohol in the upper respiratory tracts is considered as not beingpresent or negligible. One of the two following solutions shall be chosen:
(AA) the smallest value of the measurement results is displayed and printed;
(AB) the two values are displayed and printed.
(B) Case 2: if R is greater than or equal to 0.03 min—1, the results are considered as being affected by alcohol in the upper respiratory tracts and the measurement cycle shall be cancelled. The EBA shall display an appropriate error message to specify that the measurement cycle is not valid.
Note: To ensure the test results, the testing laboratory shall repeat the two measurement cycles.
(2) Test procedure of the two-measurement cycle - First method:
Note that the test gases described in this procedure are chosen for an allowed limit of 0.25 mg/L. For other limits, the required test gas concentrations must be adapted accordingly.
Table B.2 - Two-measurement cycle - First method.
| Serial | Test method. | Measurements with defined differences of ethanol concentration |
| Number | | |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers with a two-measurement cycle for detecting alcohol in the upper respiratory tract. |
| 2. | Object of the test. | Verification of compliance with the provisions in clause (viii) of sub-paragraph (1) of paragraph 2 of Part 2, under ambient reference conditions. |
| 3. | Precondition. | As defined in clause (ii) of sub-paragraph (5) of paragraph 6 of Part 2. |
| 4. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 5. | Test procedure in Brief. | The test comprises of 5 measurements with a two-measurement cycle for each incident and case. |
| 6. | Test gases Mass | (i) Incident (a) |
| | | Test gas A: allowed limit minus 0.03 mg/L = 0.22 mg/L |
| | | (ii) Incident (b) |
| | | Test gas B: allowed limit plus 0.03 mg/L = 0.28 mg/L and |
| | | Test gas A: allowed limit minus 0.03 mg/L = 0.22 mg/L |
| | | (iii) Incident (c) |
| | | (a) First test gas: |
| | | test gas B: allowed limit plus 0.03 mg/L = 0.28 mg/L |
| | | (b) Second test gas: |
| | | (I) Case 1: Test gas C |
| | | concentrationof | One of these test gas | Time delay | Second test gas | Theoretical ratio R |
| | ethanol. | concentrations shall be | (min) | (mg/L)0.29 | (min—1) |
| | | chosen as second | 2 | 0.29 | |
| | | test gas C, depending onthe | 2.5 | 0.29 | 0.017 |
| | | time delay: | 3 | 0.30 | 0.014 |
| | | | 3.5 | 0.30 | 0.022 |
| | | | 4 | 0.30 | 0.019 |
| | | | 4.5 | 0.31 | 0.017 |
| | | | 5 | 0.31 | 0.022 |
| | | | | | 0.019 |
| | | (II) Case 2: | Test gas D | |
| | | One of these test gas | Time delay | Second test gas | Theoretical ratio R |
| | | concentrations shall be | (min) | (mg/L)0.30 | (min—1) |
| | | chosen as second | 2 | 0.30 | 0.033 |
| | | test gas D, dependingon the | 2.5 | 0.31 | 0.039 |
| | | time delay: | 3 | 0.31 | 0.032 |
| | | | 3.5 | 0.32 | 0.036 |
| | | | 4 | 0.32 | 0.031 |
| | | | 4.5 | 0.33 | 0.034 |
| | | | 5 | 0.34 | 0.035 |
| 7. | Measurement conditions. | (i) Test gas generator: Type 1 or type 2 |
| | | (ii) Variation of the alcohol concentration as a function of time: |
| | | (a) no variation (type 1 test gas generator) or |
| | | (b) plateau duration equal to 3 s (type 2 test gas generator). |
| | | (iii) Ethanol concentrations: See above at serial number 6. |
| | | (iv) Test gas conditions: |
| | | (a) Delivered volume: 3 L ± 0.1 L |
| | | (b) Duration of injection: 5 s ± 0.5 s |
| | | (c) All other parameters as defined in Table 4 of sub-clause (a) of clause (iii) of sub paragraph (4) of paragraph 6 of Part 2 and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (v) Ambient conditions: Within reference conditions as defined in Clause (i) of sub paragraph (4) of paragraph 6 of Part 2. |
| 8. | Test schemes. | (i) Test scheme for incident (a) |
| | | (a) test gas concentration for the first measurement: test gas A |
| | | (b) the second measurement shall not be performed (the EBA shall terminate the measurement cycle automatically after the first test) |
| | | (ii) Test scheme for incident (b) |
| | | (a) test gas concentration for the first measurement: test gas B |
| | | (b) test gas concentration for the second measurement: test gas A |
| | | (iii) Test scheme for incident (c) |
| | | (a) Case 1: R is less than 0.03 min—1: |
| | | (I) test gas concentration for the first measurement: test gas B |
| | | (II) test gas concentration for the second measurement: one of the test gases listed as C, depending on the time between the end of the first injection and the end of the second injection to obtain a theoretical ratio of less than 0.03 |
| | | (b) Case 2: R is greater than or equal to 0.03 min—1: |
| | | (I) test gas concentration for the first measurement: test gas B |
| | | (II) test gas concentration for the second measurement: one of the test gases listed as D, depending on the time between the end of the first injection and the end of the second injection to obtain a theoretical ratio of greater than or equal to 0.03. |
| 9. | EUT performance. | (i) Number of measurements per test scheme: at least 5. |
| | | (ii) Time schedule: to be performed consecutively for each test scheme. |
| | | (iii) Parameters at least to be recorded: as defined in clause (iii) of sub—paragraph (5) of paragraph 6 of Part 2 |
| 10. | Acceptance criteria. | (i) For incident (a): |
| | | The EUT shall verify that the result β1 of the first measurement is below the allowed limit (β1 < 0.25 mg/L), and shall display and print the result. |
| | | (ii)For incident (b): |
| | | The EUT shall verify that the result of the second measurement β2 is below the allowed limit (β2 < 0.25 mg/L), and shall display and print the smallest result. |
| | | (iii) For incident (c), case 1: |
| | | The EUT shall verify that the ratio R obtained from both results β1 and β2 is smaller than 0.03 min—1 and shall either display and print (if applicable) the smallest result of β1 and β2 as the final result of a valid measurement cycle, or display and print both results β1 and β2. |
| | | (iv) For incident (c), case 2: |
| | | The EUT shall verify that the ratio R obtained from both results β1 and β2 is greater than or equal to 0.03 min—1 and shall cancel the measurement cycle and display an appropriate error message. |
(3) Principle of the two-measurement cycle - Second method:
(i) The cycle of the EBA shall consist of two measurements of separate breath samples. The time delay between the measurements of the two breath samples measurements shall be between 2 min and 5 min and the final result of both measurements shall be obtained (for example lower result, mean of
both results, or both results).
(ii) If the difference between the two measurement results is more than 0.10 mg/L, or 20 % of the smaller of the two measurement results, depending on whichever is the greater, the EBA shall automatically shall cancel the measurement cycle as invalid and shall display an appropriate error message.
(4) Test procedure of the two-measurement cycle second method:
Table B.3 –Two-measurement cycle-second method.
| Serial | Test method. | Measurements with different ethanol concentrations for the two |
| Number | | measurements of a measurement cycle. |
|---|---|---|
| (1) | (2) | (3) |
| 1. | Applicability. | Applicable to all Breath analysers with a two-measurement cycle for detecting alcohol in the upper respiratory tract. |
| 2. | Object of the test. | Verification of compliance with the provisions in clause (vii) of sub paragraph (1) of paragraph 6 of Part 2, under ambient reference conditions. |
| 3. | Precondition. | As defined in clause (ii) of sub-paragraph (5) of paragraph 6 of Part 2. |
| 4. | Condition of the EUT. | Power is to be ―on‖ for the duration of the test. |
| 5. | Test procedure in brief. | The test comprises of 5 measurements with the special test gas. |
| 6. | Measurement conditions. | (i) Test gas generator: type 1 or type 2. |
| | | (ii) Variation of the alcohol concentration as a function of time: |
| | | (a) no variation (type 1 test gas generator); or |
| | | (b) plateau duration equal to 3s (type 2 test gas generator). |
| | | (iii) Ethanol concentrations: |
| | | (a) Test gas concentration for the first measurement: 0.40 mg/L (test gas no. 4) |
| | | (b) Test gas concentration for the second measurement: 0.25 mg/L (test gas no. 3) |
| | | (c) Test gas conditions: |
| | | (I) delivered volume: 3 L ± 0.1 L |
| | | (II) duration of injection: 5 s ± 0.5 s |
| | | (III) all other parameters as defined in Table 4 under sub-clause (a) of clause (iii) of sub-paragraph (4) of paragraph 6 of Part 2 and Table 6 under sub-clause (b) of clause (iii) of the said sub-paragraph. |
| | | (iv) Ambient conditions: within reference conditions as defined in clause (i) of sub-paragraph (4) of paragraph 6 of part 2. |
| 7. | EUT performance. | (i) Number of measurements per test scheme: at least 5. |
| | | (ii) Time schedule: to be performed consecutively at each test scheme. |
| | | (iii) Parameters at least to be recorded: as defined in clause (iii) of sub-paragraph (5) of paragraph 6 of Part 2. |
| 8. | Acceptance criteria. | (i) The equipment under test shall calculate the difference in the ethanol concentration between the two measurements and shall not calculate/ display a final result, if the difference between the two measurement results is >0.10 mg/L or 20% of the smaller of the two measurement results, depending on whichever is the greater. |
| | | (ii) It shall not deliver any measurement result and shall display an appropriate error message. |
3. Delay before measurement:
An observation period of at least fifteen (15) minutes shall be observed before conducting a breath test, regardless of the technical features of the device, to ensure that any alcohol present in the upper respiratory tract has dissipated.‘.
[No. WM-9(9)/2024]
ANUPAM MISHRA, Jt. Secy.
Note:- The Legal Metrology (General) Rules, 2011 were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide notification number G.S.R.71(E), dated the 7th February, 2011 and was last amended, vide notification number G.S.R. 536 (E), dated the 07th August, 2025.