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Core Purpose

Notification by the Bureau of Indian Standards establishing new Indian Standards and specifying the withdrawal dates of the corresponding superseded standards, under rule 15(1) of the Bureau of Indian Standards Rules, 2018.

Detailed Summary

Vide Notification Ref. HQ-PUB013/1/2020-PUB-BIS(1083) dated 11th November 2024, the Bureau of Indian Standards (Department of Consumer Affairs), in pursuance of sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, notified that a set of Indian Standards, mostly effective 29th October 2024, have been established, while the corresponding superseded standards remain concurrently in force until their withdrawal on 29th April 2025. The scheduled standards, largely covering medical devices, include: IS 4487:2024 (ENT Surgery Instruments — Forceps, Tonsil Artery, Birkett's Pattern, Second Revision), replacing IS 4487:2000; IS 8254 (Part 2):2024 (Valve, Non-Rebreathing, Part 2 Ambu-Hesse's Pattern), replacing IS:8254 (Part II)-1976; IS/ISO 11979-3:2012 (Ophthalmic Implants — Intraocular Lenses, Part 3 Mechanical Properties and Test Methods, First Revision), replacing IS/ISO 11979-3:2006; IS 18292 (Part 1):2024 (ISO 10555-1:2023, Intravascular Catheters — Sterile and Single-Use Catheters, Part 1 General Requirements), replacing IS/ISO 10555-1:2013; IS 18292 (Part 4):2024 (ISO 10555-4:2023, Part 4 Balloon Dilatation Catheters), replacing IS/ISO 10555-4:2013; IS 18319:2024 (ISO 17665:2024, Sterilization of Health Care Products — Moist Heat, First Revision), replacing IS 18319 (Part 1):2023/ISO 17665-1:2006; IS 18827:2024 (ISO 5361:2023, Anaesthetic and Respiratory Equipment — Tracheal Tubes and Connectors), replacing IS:4154-1967, IS/ISO 5361:1999, IS:6581-1972 and IS:6807-1972; IS 18834:2024 (Anaesthetic and Respiratory Equipment — Supralaryngeal Airways and Connectors, ISO 11712:2023 MOD), replacing IS:3392-1965 and IS/ISO 11712:2009; IS 18858:2024 (ISO 22674:2022, Dentistry — Metallic Materials for Fixed and Removable Restorations and Appliances), replacing IS/ISO 22674:2016; IS 18865 (Part 7):2024 (ISO 21549-7:2024, Health Informatics — Patient Healthcard Data, Part 7 Medication Data), replacing IS/ISO 21549-7:2016; and IS 18867 (Part 2):2024 (ISO 22077-2:2023, Health Informatics — Medical Waveform Format, Part 2 Electrocardiography), replacing IS/ISO/TS 22077-2:2015, with the list continuing beyond the extracted text.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-20112024-258778 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 921] NEW DELHI, TUESDAY, NOVEMBER 19, 2024/KARTIKA 28, 1946 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi the,11 November 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1083).—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 | Date of | No., Year & Title of the | Date of | | No. | Indian Standards | Establishment | Indian Standards to be | Withdrawal | | | Established | | Withdrawn, if any | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | (1) | (2) | (3) | (4) | (5) | +=====+===================================+====================+===========================================+===================+ | 1 | IS 4487: 2024 | 29 October | IS 4487: 2000 | 29 April | | | ENT Surgery Instruments — | 2024 | Ent Surgery Instruments | 2025 | | | Forceps, Tonsil Artery | | — Forceps, Tonsil Artery | | | | (Birkett's Pattern) — | | (Birkett's Pattern) - | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | | Specification | | Specification | | | | (Second Revision) | | (First Revision) | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 2 | IS 8254 (Part 2) : 2024 | 29 October | IS : 8254 (Part II ) — | 29 April | | | Valve, Non-Rebreathing — | 2024 | 1976 | 2025 | | | Specification | | Specification for Valve, | | | | Part 2 Ambu-Hesse's Pattern | | Non-Rebreathing | | | | (First Revision) | | Part II Ambu-Hesse's | | | | | | Pattern | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 3 | IS/ISO 11979-3 : 2012 | 29 October | IS/ISO 11979-3 : 2006 | 29 April | | | Ophthalmic Implants — | 2024 | Ophthalmic Implants — | 2025 | | | Intraocular Lenses | | Intraocular Lenses | | | | Part 3 Mechanical Properties | | Part 3 Mechanical | | | | and Test Methods | | Properties and Test | | | | (First Revision) | | Methods | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 4 | IS 18292 (Part 1) : 2024 | 29 October | IS/ISO 10555-1 : 2013 | 29 April | | | ISO 10555-1: 2023 | 2024 | Intravascular Catheters — | 2025 | | | Intravascular Catheters — | | Sterile and Single-Use | | | | Sterile and Single-Use | | Catheters Part 1 General | | | | Catheters | | Requirements | | | | Part 1 General Requirements | | (First Revision) | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 5 | IS 18292 (Part 4) : 2024 | 29 October | IS/ISO 10555-4: 2013 | 29 April | | | ISO 10555-4: 2023 | 2024 | Intravascular Catheters — | 2025 | | | Intravascular Catheters — | | Sterile and Single-Use | | | | Sterile and Single-Use | | Catheters Part 4 Balloon | | | | Catheters | | Dilatation Catheters | | | | Part 4 Balloon Dilatation | | (First Revision) | | | | Catheters | | | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 6 | IS 18319: 2024 | 29 October | IS 18319 (Part 1) : 2023 | 29 April | | | ISO 17665 : 2024 | 2024 | ISO 17665-1: 2006 | 2025 | | | Sterilization of Health Care | | Sterilization of Health | | | | Products — Moist Heat — | | Care Products — Moist | | | | Requirements for the | | Heat | | | | Development, Validation and | | Part 1 Requirements for | | | | Routine Control of a | | the Development | | | | Sterilization Process for | | Validation and Routine | | | | Medical Devices | | Control of a Sterilization | | | | (First Revision) | | Process for Medical | | | | | | Devices | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 7 | IS 18827: 2024 | 29 October | IS: 4154-1967 | 29 April | | | ISO 5361: 2023 | 2024 | Specification for | 2025 | | | Anaesthetic and Respiratory | | Endotracheal | | | | Equipment Tracheal Tubes and | | Connections | | | | Connectors | | | | | | | | IS/ISO 5361 : 1999 | | | | | | Anaesthetic and | | | | | | Respiratory Equipment | | | | | | — Tracheal Tubes and | | | | | | Connectors | | | | | | | | | | | | IS: 6581-1972 | | | | | | Specification for | | | | | | Endotracheal Tubes | | | | | | (Rubber ) | | | | | | | | | | | | IS: 6807-1972 | | | | | | Specification for | | | | | | Reinforced | | | | | | ( | | | | | | Flexo-Metallic) Magill's | | | | | | Endotracheal Tube | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 8 | IS 18834: 2024 | 29 October | IS: 3392-1965 | 29 April | | | Anaesthetic and Respiratory | 2024 | Specification for | 2025 | | | Equipment — Supralaryngeal | | Anaesthetic Airways | | | | Airways and Connectors | | | | | | (ISO 11712 : 2023, MOD) | | IS/ISO 11712: 2009 | | | | | | Anaesthetic and | | | | | | Respiratory Equipment | | | | | | Supralaryngeal | | | | | | Airways and Connectors | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 9 | IS 18858: 2024 | 29 October | IS/ISO 22674 : 2016 | 29 April | | | ISO 22674 : 2022 | 2024 | Dentistry — Metallic | 2025 | | | Dentistry — Metallic Materials | | Materials for Fixed and | | | | for Fixed and Removable | | Removable Restorations | | | | Restorations and Appliances | | and Appliances | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 10 | IS 18865 (Part 7) : 2024 | 29 October | IS/ISO 21549-7: 2016 | 29 April | | | ISO 21549-7: 2024 | 2024 | Health Informatics — | 2025 | | | Health Informatics — Patient | | Patient Healthcard Data | | | | Healthcard Data | | Part 7 Medication Data | | | | Part 7 Medication Data | | | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 11 | IS 18867 (Part 2) : 2024 | 29 October | IS/ISO/TS 22077-2 : | 29 April | | | ISO 22077-2: 2023 | 2024 | 2015 | 2025 | | | Health Informatics — Medical | | Health Informatics — | | | | Waveform Format | | Medical Waveform | | | | Part 2 Electrocardiography | | Format | | | | | | Part 2 | | | | | | Electrocardiography | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 12 | IS 18867 (Part 3) : 2024 | 29 October | IS/ISO/TS 22077-3 : | 29 April | | | ISO 22077-3 : 2023 | 2024 | 2015 | 2025 | | | Health Informatics — Medical | | Health Informatics — | | | | Waveform Format | | Medical Waveform | | | | Part 3 Long-Term | | Format | | | | Electrocardiography | | Part 3 Long Term | | | | | | Electrocardiography | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 13 | IS 18869: 2024 | 29 October | IS/ISO/TS 14265 : 2011 | 29 April | | | ISO/TS 14265: 2024 | 2024 | Health Informatics — | 2025 | | | Health Informatics — | | Classification of Purposes | | | | Classification of Purposes for | | for Processing Personal | | | | Processing Personal Health | | Health Information | | | | Information | | | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 14 | IS 18875 (Part 10425) : 2024 | 29 October | IS/ISO/IEEE 11073- | 29 April | | | ISO/IEEE 11073-10425 : 2019 | 2024 | 10425: 2016 | 2025 | | | Health Informatics - Personal | | Health Informatics — | | | | Health Device Communication | | Personal Health Device | | | | Part 1425 Device | | Communication Part | | | | Specialization — Continuous | | 10425 Device | | | | Glucose Monitor (CGM) | | Specialization — | | | | | | Continuous Glucose | | | | | | Monitor (CGM) | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ | 15 | IS 18881 (Part 5) : 2024 | 29 October | NA | NA | | | ISO 13408-5: 2006 | 2024 | | | | | Aseptic Processing of Health | | | | | | Care Products | | | | | | Part 5 Sterilization in Place | | | | +-----+-----------------------------------+--------------------+-------------------------------------------+-------------------+ CHITRA GUPTA,Scientist G & DDG (Hallmarking) [Advt. -III/4/Exty./690/2024-25] 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. GORAKHA NATH YADAVA

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