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Core Purpose

Notification by the Bureau of Indian Standards under rule 15(1) of the Bureau of Indian Standards Rules, 2018, establishing new Indian Standards for medical, dental and laboratory equipment and specifying withdrawal dates for certain superseded standards.

Detailed Summary

Reference HQ-PUB013/1/2020-PUB-BIS(1009) and advertisement No. ADVT.-III/4/Exty./423/2024-25 dated 16 August 2024, issued by the Bureau of Indian Standards (Department of Consumer Affairs) under sub-rule (1) of rule 15 of the Bureau of Indian Standards Rules, 2018, establishes, with effect from 14 August 2024, a schedule of Indian Standards including IS 4444:2024 'Medical Laboratory Glassware - Bacteriological Bottles - Specification (First Revision)', which withdraws IS 4444-1967 effective 14 February 2025, and IS 13701:2024 (ISO 8325:2023) 'Dentistry - Test Methods for Rotary Instruments (Second Revision)', which withdraws IS 13701:2018 effective 14 February 2025, alongside newly established dentistry- and medical-device-related standards without corresponding withdrawals, namely IS 17859 (Part 4):2024, IS 18474 (Part 5):2024, IS 18490:2024, IS 18681 (Part 4):2024, IS 18683 (Part 2):2024, IS 18730:2024, IS 18744:2024, IS 18790 (Part 2):2024, IS 18798:2024 and IS 18810:2024; signed by P. Rajesh, Scientist G and Deputy Director General (ITS, PRT & TNM).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-24082024-256636 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 654] NEW DELHI, FRIDAY, AUGUST 23, 2024/BHADRA 1, 1946 P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 16th August, 2024 [ADVT.-III/4/Exty./423/2024-25] Ref: HQ-PUB013/1/2020-PUB-BIS (1009).—In pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Indian standards, particulars of which are given in the second column of the schedule hereto annexed have been established on the date indicated against it in third column. The particulars of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column. SCHEDULE +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | SI. | No., Year & Title of the Indian | Date of | No., Year & Title of the | Date of | | No. | Standards Established | Establishment | Indian Standards to be | Withdrawal | | (1) | (2) | (3) | Withdrawn, if any | (5) | |========+======================================================+=======================+=================================================================+====================| | 1 | IS 4444: 2024 | 14 August 2024 | IS 4444 - 1967 | 14 February | | | Medical Laboratory Glassware — | | Specification for Bottles, | 2025 | | | Bacteriological Bottles — Specification | | Bacteriological | | | | (First Revision) | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 2 | IS 13701: 2024 | 14 August 2024 | IS 13701: 2018 | 14 February | | | ISO 8325: 2023 | | ISO 8325: 2004 | 2025 | | | Dentistry — Test Methods for Rotary | | Dentistry — Test Methods for | | | | Instruments | | Rotary Instruments | | | | (Second Revision) | | (First Revision) | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 3 | IS 17859 (Part 4): 2024 | 14 August 2024 | NA | NA | | | ISO 3630-4: 2023 | | | | | | Dentistry — Endodontic Instruments | | | | | | Part 4 Auxiliary Instruments | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 4 | IS 18474 (Part 5): 2024 | 14 August 2024 | NA | NA | | | ISO 1135-5: 2015 | | | | | | Transfusion Equipment for Medical Use | | | | | | Part 5 Transfusion Sets for Single Use | | | | | | with Pressure Infusion Apparatus | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 5 | IS 18490: 2024 | 14 August 2024 | NA | NA | | | ISO 18618:2022 | | | | | | Dentistry - Interoperability of | | | | | | CAD/CAM Systems | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 6 | IS 18681 (Part 4): 2024 | 14 August 2024 | NA | NA | | | ISO 6360-4: 2004 | | | | | | Dentistry - Number Coding System for | | | | | | Rotary Instruments | | | | | | Part 4 Specific Characteristics of | | | | | | Diamond Instruments | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 7 | IS 18683 (Part 2): 2024 | 14 August 2024 | NA | NA | | | ISO 7711-2: 2011 | | | | | | Dentistry — Rotary Diamond | | | | | | Instruments | | | | | | Part 2 Discs | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 8 | IS 18730: 2024 | 14 August 2024 | NA | NA | | | ISO 14160: 2020 | | | | | | Sterilization of Health Care Products — | | | | | | Liquid Chemical Sterilizing Agents for | | | | | | Single-Use Medical Devices Utilizing | | | | | | Animal Tissues and their Derivatives — | | | | | | Requirements for Characterization, | | | | | | Development, Validation and Routine | | | | | | Control of a Sterilization Process for | | | | | | Medical Devices | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 9 | IS 18744: 2024 | 14 August 2024 | NA | NA | | | ISO 20069: 2019 | | | | | | Guidance for Assessment and | | | | | | Evaluation of Changes to Drug Delivery | | | | | | Systems | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 10 | IS 18790 (Part 2): 2024 | 14 August 2024 | NA | NA | | | ISO 5467-2: 2022 | | | | | | Dentistry — Mobile Dental Units and | | | | | | Dental Patient Chairs | | | | | | Part 2 Air, Water, Suction and | | | | | | Wastewater Systems | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 11 | IS 18798: 2024 | 14 August 2024 | NA | NA | | | ISO 11609: 2017 | | | | | | Dentistry — Dentifrices — | | | | | | Requirements, Test Methods and | | | | | | Marking | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 12 | IS 18810: 2024 | 14 August 2024 | NA | NA | | | ISO 21606: 2022 | | | | | | Dentistry — Elastomeric Auxiliaries for | | | | | | Use in Orthodontics | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 13 | IS 18811 (Part 1): 2024 | 14 August 2024 | NA | NA | | | ISO 23401-1: 2023 | | | | | | Dentistry — Chairside Denture Base | | | | | | Relining Materials | | | | | | Part 1 Hard Type Materials | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 14 | IS 18813: 2024 | 14 August 2024 | IS 8571-1977 | 14 August | | | ISO 6872: 2015 | | Specification for Dental | 2024 | | | Dentistry — Ceramic Materials | | Porcelain | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 15 | IS 18822: 2024 | 14 August 2024 | NA | NA | | | ISO 16408: 2015 | | | | | | Dentistry — Oral Care Products — Oral | | | | | | Rinses | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 16 | IS 18823: 2024 | 14 August 2024 | NA | NA | | | ISO 7551: 2023 | | | | | | Dentistry — Endodontic Absorbent | | | | | | Points | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 17 | IS 18825: 2024 | 14 August 2024 | NA | NA | | | ISO 18675: 2022 | | | | | | Dentistry — Machinable Ceramic | | | | | | Blanks | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ | 18 | IS 18826: 2024 | 14 August 2024 | NA | NA | | | ISO 22112: 2017 | | | | | | Dentistry — Artificial Teeth for Dental | | | | | | Prostheses | | | | +--------+------------------------------------------------------+-----------------------+-----------------------------------------------------------------+--------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./423/2024-25] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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