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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 an amendment to an Indian Standard.

Detailed Summary

The Bureau of Indian Standards (Department of Consumer Affairs), vide Notification Ref. HQ-PUB015/1/2020-PUB-BIS (896) dated 28th May 2024, notified under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018 that Amendment No. 2 (May 2024) to Indian Standard IS/ISO 11137-1:2006 'Sterilization of Health Care Products - Radiation, Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices' has been established with effect from 21 May 2024, with the standard without this amendment remaining in force until 20 June 2024; the notification was issued by P. Rajesh, Scientist G & DDG (ITS, PRT & TNM), under Advertisement No. ADVT.-III/4/Exty./153/2024-25.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-01062024-254497 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 384] NEW DELHI, THURSDAY, MAY 30, 2024/JYAISHTHA 9, 1946 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III-SEC.4] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 28th May, 2024 Ref: HQ-PUB015/1/2020-PUB-BIS (896).—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 Standard | No. and Month/Year of the Amendment | Date of Establishment of the Amendment | Date till which the standard without the amendment as mentioned in column 3 shall remain in force | | No. | | | | (5) | +=====+=====================================================+===================================+===================================+====================================================================================================================+ | (1) | (2) | (3) | (4) | | +-----+-----------------------------------------------------+-----------------------------------+-----------------------------------+--------------------------------------------------------------------------------------------------------------------+ | 1 | IS/ISO 11137-1:2006 | Amendment No. 2 | 21 May 2024 | 20 June 2024 | | | Sterilization of Health Care Products — Radiation | May 2024 | | | | | Part 1 Requirements for Development, Validation and | | | | | | Routine Control of a Sterilization Process for | | | | | | Medical Devices | | | | +-----+-----------------------------------------------------+-----------------------------------+-----------------------------------+--------------------------------------------------------------------------------------------------------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./153/2024-25] 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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