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Core Purpose

Notification by the Bureau of Indian Standards under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018 establishing a set of Indian Standards for medical and dental instruments and specifying withdrawal dates of certain corresponding earlier standards.

Detailed Summary

By notification Ref: HQ-PUB012/4/2020-PUB-BIS(994) dated 1st August 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 the establishment, effective 31 July 2024, of Indian Standards including: IS 3393:2024 (Mouth Props and Airways, London Hospital Pattern, First Revision), replacing IS 3393-1965, withdrawn 31 January 2025; IS 8254 (Part 1):2024 (Valve, Non-Rebreathing, Ruben's Pattern, First Revision), replacing IS 8254 (Part I)-1976, withdrawn 31 January 2025; IS 10568:2024 (Teat Knife-McLean's, First Revision), replacing IS 10568-1983, withdrawn 31 January 2025; IS 10183:2024 (Self-Retaining Retractor for Laminectomy, First Revision), replacing IS 10183-1982, withdrawn 31 January 2025; IS 10258 (Part 2):2024 (based on ISO 7886-2:2020, Sterile Hypodermic Syringes for Single Use, Power-Driven Syringe Pumps), no standard withdrawn; IS 17859 (Part 2):2024 (based on ISO 3630-2:2023, Dentistry Endodontic Instruments Enlargers), no standard withdrawn; IS 18493 (Part 6):2024 (based on ISO 15087-6:2000, Dental Elevators, Flohr Elevators), no standard withdrawn; IS 18502 (Part 2):2024 (based on ISO 16635-2:2014, Dental Rubber Dam Instruments, Clamp Forceps), replacing IS 5965-1970, withdrawn 31 January 2025; IS 18529:2024 (based on ISO 11070:2014, Sterile Single-Use Intravascular Introducers, Dilators and Guidewires), no standard withdrawn; IS 18697 (Part 4):2024 (based on ISO 10651-4:2023, Lung Ventilators, User-Powered Resuscitators, First Revision), replacing IS/ISO 10651-4:2002, withdrawn 31 January 2025; IS 18742 (Part 2):2024 (based on ISO 17664-2:2021, Processing of Health Care Products, Non-Critical Medical Devices), no standard withdrawn; and IS 18780:2024 (based on ISO 21533:2018, Dentistry Reprocessable Cartridge Syringes for Intraligamentary Injections), no standard withdrawn.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India No. 637] CG-DL-E-20082024-256489 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY NEW DELHI, FRIDAY, AUGUST 16, 2024/SHRAVANA 25, 1946 5253 GI/2024 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 1st August, 2024 Ref: HQ-PUB012/4/2020-PUB-BIS (994).—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.| No., Year & Title of the Indian Standards Established | Date of | No., Year & Title of the Indian Standards to be withdrawn, | Date of | | | | Establishment | if any | withdrawal | +=======+==============================================================+================+=============================================================+===================+ | (1) | (2) | (3) | (4) | (5) | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 1 | IS 3393: 2024 | 31 July 2024 | IS 3393-1965 | 31 January 2025 | | | Mouth Props and Airways | | Specification for Mouth Props | | | | (London Hospital Pattern) – | | and Airways (London Hospital | | | | Specification | | Pattern) | | | | (First Revision) | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 2 | IS 8254 (Part 1): 2024 | 31 July 2024 | IS 8254 (Part I) – 1976 | 31 January 2025 | | | Valve, Non-Rebreathing — | | Specification for Valve, Non- | | | | Specification | | Rebreathing | | | | Part 1 Ruben's Pattern | | Part 1 Ruben's Pattern | | | | (First Revision) | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 3 | IS 10568: 2024 | 31 July 2024 | IS 10568-1983 | 31 January 2025 | | | Teat Knife - McLean's — | | Specification for Knife, Teat, | | | | Specification | | McLean | | | | (First Revision) | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 4 | IS 10183: 2024 | 31 July 2024 | IS 10183-1982 | 31 January 2025 | | | Self-Retaining Retractor for | | Specification for Retractor, | | | | Laminectomy | | Deep, Self-Retaining, | | | | (First Revision) | | Laminectomy | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 5 | IS 10258 (Part 2): 2024 | 31 July 2024 | NA | NA | | | ISO 7886-2: 2020 | | | | | | Sterile Hypodermic Syringes for | | | | | | Single Use | | | | | | Part 2 Syringes for Use with | | | | | | Power-Driven Syringe Pumps | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 6 | IS 17859 (Part 2) : 2024 | 31 July 2024 | NA | NA | | | ISO 3630-2: 2023 | | | | | | Dentistry Endodontic | | | | | | Instruments | | | | | | Part 2 Enlargers | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 7 | IS 18493 (Part 6) : 2024 | 31 July 2024 | NA | NA | | | ISO 15087-6: 2000 | | | | | | Dental Elevators | | | | | | Part 6 Flohr Elevators | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 8 | IS 18502 (Part 2): 2024 | 31 July 2024 | IS 5965-1970 | 31 January 2025 | | | ISO 16635-2: 2014 | | Specification for Frame, | | | | Dentistry - Dental Rubber Dam | | Rubber Dam, Dental | | | | Instruments | | | | | | Part 2 Clamp Forceps | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 9 | IS 18529: 2024 | 31 July 2024 | NA | NA | | | ISO 11070: 2014 | | | | | | Sterile Single-Use Intravascular | | | | | | Introducers, Dilators and | | | | | | Guidewires | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 10 | IS 18697 (Part 4): 2024 | 31 July 2024 | IS/ISO 10651-4: 2002 | 31 January 2025 | | | Lung Ventilators | | Lung Ventilators for Medical | | | | Part 4 Particular Requirements for | | Use Particular | | | | User- Powered Resuscitators | | Requirements for Basic Safety | | | | (ISO 10651-4: 2023, MOD) | | and Essential Performance | | | | (First Revision) | | Part 4 Particular Requirements | | | | | | for Operator-Powered | | | | | | Resuscitators | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 11 | IS 18742 (Part 2): 2024 | 31 July 2024 | NA | NA | | | ISO 17664-2: 2021 | | | | | | Processing of Health Care | | | | | | Products -Information to be | | | | | | Provided by the Medical Device | | | | | | Manufacturer for the Processing of | | | | | | Medical Devices | | | | | | Part 2 Non-Critical Medical | | | | | | Devices | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 12 | IS 18780: 2024 | 31 July 2024 | NA | NA | | | ISO 21533:2018 | | | | | | Dentistry - Reprocessable | | | | | | Cartridge Syringes for | | | | | | Intraligamentary Injections | | | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ | 13 | IS 18789: 2024 | 31 July 2024 | IS 6037-1970 | 31 January 2025 | | | ISO 3107: 2022 | | Specification for Zinc Oxide- | | | | Dentistry - Zinc Oxide-Eugenol | | Eugenol Dental Impression | | | | Cements and Non-Eugenol Zinc | | Paste | | | | Oxide Cements | | IS 6039-1970 | | | | | | Specification for Zinc Oxide- | | | | | | Eugenol Dental Cement | | | | | | IS 10012- 1981 | | | | | | Specification for Dental Zinc | | | | | | Oxide/Eugenol Filling | | | | | | Meterials | | +-------+--------------------------------------------------------------+----------------+-------------------------------------------------------------+-------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./400/2024-25] 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. SARVESH KUMAR SRIVASTAVA Digitally signed by SARVESH KUMAR SRIVASTAVA Date: 2024.08.20 21:09:43 +05'30'

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