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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 Amendment No. 1 to two Indian Standards on sterilization of health care products.

Detailed Summary

Pursuant to sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards (Department of Consumer Affairs) issued a notification dated 24th April 2024 (Ref: HQ-PUB015/1/2020-PUB-BIS(838)) notifying the establishment, effective 22 April 2024, of Amendment No. 1 (April 2024) to two Indian Standards, IS/ISO 11137-2:2013 "Sterilization of Health Care Products - Radiation, Part 2: Establishing the Sterilization Dose" and IS/ISO 11737-1:2018 "Sterilization of Health Care Products - Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products", with both standards remaining in force without the amendment until 21 May 2024; the notification was signed by P. Rajesh, Scientist G and Deputy Director General (ITS, PRT & TNM), under Advertisement No. ADVT.-III/4/Exty./064/2024-25.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-30042024-253968 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 295] NEW DELHI, MONDAY, APRIL 29, 2024/VAISAKHA 9, 1946 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 24th April, 2024 Ref: HQ-PUB015/1/2020-PUB-BIS(838).—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 Amendments to Indian standards, particulars of which are given in schedule hereto annexed have been established. SCHEDULE +-----+----------------------------------------------------------------------------------------------------------------+-----------------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------------+ | Sl. | No., Year & Title of the Indian | No. and | Date of | Date till which | | No. | Standard | Month/Year of | Establishment | the standard | | | | the Amendment | of the | without the | | | | | Amendment | amendment as | | | | | | mentioned in | | | | | | column 3 shall | | | | | | remain in force | +=====+================================================================================================================+===================================+=============================+=======================================================================================================================+ | (1) | (2) | (3) | (4) | (5) | +-----+----------------------------------------------------------------------------------------------------------------+-----------------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------------+ | 1 | IS/ISO 11137-2: 2013 | Amendment No. 1 | 22 April 2024 | 21 May 2024 | | | Sterilization of Health Care Products— | April 2024 | | | | | Radiation | | | | | | Part 2 Establishing the Sterilization | | | | | | Dose | | | | +-----+----------------------------------------------------------------------------------------------------------------+-----------------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------------+ | 2 | IS/ISO 11737-1: 2018 | Amendment No. 1 | 22 April 2024 | 21 May 2024 | | | Sterilization of Health Care Products— | April 2024 | | | | | Microbiological Methods | | | | | | Part 1 Determination of a Population of | | | | | | Microorganisms on Products | | | | +-----+----------------------------------------------------------------------------------------------------------------+-----------------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./064/2024-25] 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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