Gazette Tracker
Gazette Tracker

Core Purpose

Notification by the Bureau of Indian Standards establishing ten Indian Standards relating to medical and healthcare device equipment under Rule 15(1) of the Bureau of Indian Standards Rules, 2018.

Detailed Summary

Bureau of Indian Standards (Department of Consumer Affairs) notification Ref: HQ-PUB013/1/2020-PUB-BIS(1070) dated 21st October 2024, issued in pursuance of sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, notifies establishment, effective 17th October 2024, of ten Indian Standards: IS 18805:2024 (based on ISO 5359:2014+AMD1:2017, anaesthetic and respiratory equipment low-pressure hose assemblies), IS 18866:2024 (ISO 9626:2016, stainless steel needle tubing for medical devices), IS 18867(Part 1):2024 (ISO 22077-1:2022, health informatics medical waveform format encoding rules), IS 18868:2024 (ISO/TS 17988:2020, corrosion test methods for dental amalgam), IS 18870:2024 (ISO/TS 20746:2016, dental amalgam strength determination by Hertzian indentation), IS 18872:2024 (ISO 21881:2019, sterile packaged ready-for-filling glass cartridges), IS 18880:2024 (ISO 13004:2022, sterilization dose substantiation method VDmaxSD), IS 18881(Part 4):2024 (ISO 13408-4:2005, aseptic processing clean-in-place technologies), IS 18881(Part 6):2024 (ISO 13408-6:2021, aseptic processing isolator systems), and IS 18881(Part 7):2024 (ISO 13408-7:2012, alternative aseptic processes for medical devices and combination products); no prior standards are withdrawn; signed by Chitra Gupta, Scientist G & DDG (Hallmarking), under advertisement reference ADVT.-III/4/Exty./645/2024-25.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-29102024-258316 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 875] NEW DELHI, TUESDAY, OCTOBER 29, 2024/KARTIΚΑ 7, 1946 7017 GI/2024 4 THE GAZETTE OF INDIA: EXTRAORDINARY [PART III-SEC.4] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 21st October 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1070). 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 Indian | Date of | | No. | Standards Established | Establishment | Standards to be Withdrawn, if any | Withdrawal | +=====+============================================================+===================+====================================================+====================+ | (1) | (2) | (3) | (4) | (5) | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 1 | IS 18805: 2024 | 17 October 2024 | NA | NA | | | ISO 5359: 2014 | | | | | | + AMD 1: 2017 | | | | | | Anaesthetic and Respiratory | | | | | | Equipment Low-Pressure Hose | | | | | | Assemblies for Use with Medical | | | | | | Gases | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 2 | IS 18866: 2024 | 17 October 2024 | NA | NA | | | ISO 9626: 2016 | | | | | | Stainless Steel Needle Tubing for | | | | | | the Manufacture of Medical | | | | | | Devices Requirements and Test | | | | | | Methods | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 3 | IS 18867 (Part 1): 2024 | 17 October 2024 | NA | NA | | | ISO 22077-1: 2022 | | | | | | Health Informatics — Medical | | | | | | Waveform Format | | | | | | Part 1 Encoding Rules | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 4 | IS 18868: 2024 | 17 October 2024 | NA | NA | | | ISO/TS 17988: 2020 | | | | | | Dentistry — Corrosion Test | | | | | | Methods for Dental Amalgam | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 5 | IS 18870: 2024 | 17 October 2024 | NA | NA | | | ISO/TS 20746: 2016 | | | | | | Dentistry — Determination of the | | | | | | Strength of Dental Amalgam by the | | | | | | Hertzian Indentation Strength (HIT) | | | | | | Method | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 6 | IS 18872: 2024 | 17 October 2024 | NA | NA | | | ISO 21881: 2019 | | | | | | Sterile Packaged Ready for Filling | | | | | | Glass Cartridges | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 7 | IS 18880: 2024 | 17 October 2024 | NA | NA | | | ISO 13004: 2022 | | | | | | Sterilization of Health Care | | | | | | Products — Radiation — | | | | | | Substantiation of Selected | | | | | | Sterilization Dose: Method | | | | | | VDmaxSD | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 8 | IS 18881 (Part 4): 2024 | 17 October 2024 | NA | NA | | | ISO 13408-4: 2005 | | | | | | Aseptic Processing of Health Care | | | | | | Products | | | | | | Part 4 Clean-in-Place Technologies | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 9 | IS 18881 (Part 6): 2024 | 17 October 2024 | NA | NA | | | ISO 13408-6: 2021 | | | | | | Aseptic Processing of Health Care | | | | | | Products | | | | | | Part 6 Isolator Systems | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ | 10 | IS 18881 (Part 7): 2024 | 17 October 2024 | NA | NA | | | ISO 13408-7: 2012 | | | | | | Aseptic Processing of Health Care | | | | | | Products | | | | | | Part 7 Alternative Processes for | | | | | | Medical Devices and Combination | | | | | | Products | | | | +-----+------------------------------------------------------------+-------------------+----------------------------------------------------+--------------------+ CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./645/2024-25] 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. AMIT KUMAR Digitally signed by AMIT JAISWAL Date: 2024.10.29 21:58:47+05'30'

Never miss important gazettes

Create a free account to save gazettes, add notes, and get email alerts for keywords you care about.

Sign Up Free