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Core Purpose

Notification by the Bureau of Indian Standards establishing amendments to two Indian Standards relating to medical plastic containers and prefilled syringes.

Detailed Summary

By notification Ref: HQ-PUB014/2/2020-PUB-BIS(879) dated 9th May 2024, the Bureau of Indian Standards (Department of Consumer Affairs), acting under rule 15(1) of the Bureau of Indian Standards Rules, 2018, notified the establishment of Amendment No. 1 (May 2024), effective 7th May 2024, to IS/ISO 3826-1:2019 "Plastics Collapsible Containers for Human Blood and Blood Components, Part 1 Conventional Containers" (First Revision), with the unamended standard remaining valid until 6th November 2024, and Amendment No. 1 (May 2024), also effective 7th May 2024, to IS/ISO 11040-4:2015 "Prefilled Syringes, Part 4 Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling", with the unamended standard remaining valid until 6th August 2024. Issued under ADVT.-III/4/Exty./109/2024-25 and signed by P. Rajesh, Scientist G & DDG (ITS, PRT & TNM).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-13052024-254177 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 340] NEW DELHI, MONDAY, MAY 13, 2024/VAISAKHA 23, 1946 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 9th May, 2024 Ref: HQ-PUB014/2/2020-PUB-BIS (879). 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 +-----+---------------------------------------------------------+----------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------+ | SI. | No., Year & Title of the Indian Standard | No. and Month/Year | Date of | Date till which the | | No. | | of the Amendment | Establishment | standard without | | | | | of the | the amendment as | | | | | Amendment | mentioned in | | | | | | column 3 shall | | | | | | remain in force | +-----+---------------------------------------------------------+----------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------+ | (1) | (2) | (3) | (4) | (5) | +=====+=========================================================+============================+=============================+=================================================================================================================+ | 1 | IS/ISO 3826-1: 2019 | Amendment No. 1 | 07 May 2024 | 06 November 2024 | | | Plastics Collapsible Containers for Human Blood and | May 2024 | | | | | Blood Components | | | | | | Part 1 Conventional Containers | | | | | | (First Revision) | | | | +-----+---------------------------------------------------------+----------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------+ | 2 | IS/ISO 11040-4: 2015 | Amendment No. 1 | 07 May 2024 | 06 August 2024 | | | Prefilled Syringes | May 2024 | | | | | Part 4 Glass Barrels for Injectables and Sterilized | | | | | | Subassembled Syringes Ready for Filling | | | | +-----+---------------------------------------------------------+----------------------------+-----------------------------+-----------------------------------------------------------------------------------------------------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./109/2024-25]

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