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Core Purpose

Notification by the Bureau of Indian Standards establishing new and revised Indian Standards, including for medical devices, 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(1071) dated 21st October 2024, issued under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, notifies Indian Standards established with effect from 17th October 2024, including IS 16004:2024 (ISO 6009:2016) Hypodermic Needles for Single Use - Colour Coding for Identification (First Revision), which withdraws IS 16004:2013 (ISO 6009:1992) effective 17th April 2024 (concurrent validity period); IS 18784:2024 Medical Devices - Sleep Apnoea Breathing Therapy - Masks and Application Accessories (based on ISO 17510:2015, MOD); IS 18855:2024 Medical Devices - Transfusion Set and Blood Bag Compatibility Test Method (based on ISO/TS 23128:2019); IS 18857:2024 Nanotechnologies - Considerations for Performing Toxicokinetic Studies with Nanomaterials (based on ISO/TR 22019:2019); and several parts of IS 18879 Infusion Equipment for Medical Use (Parts 2, 5, 7, 9, 10 and 11), based on the corresponding ISO 8536 series standards, none of which withdraw any prior standard.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-29102024-258317 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 876] NEW DELHI, TUESDAY, OCTOBER 29, 2024/KARTIKA 7, 1946 [ADVT.-III/4/Exty./646/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 21st October 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1071). 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of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column.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 +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |Sl.N|No., Year & Title of the Indian |Date of |No., Year & Title of the |Date of | |o. |Standards Established |Establishment |Indian Standards to be |Withdrawal | | | | |Withdrawn, if any | | +====+===========================================================================================+===================+=================================================================+==================+ |(1) |(2) |(3) |(4) |(5) | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |1 |IS 16004: 2024 |17 October 2024 |IS 16004: 2013 |17 April | | |ISO 6009: 2016 | |ISO 6009: 1992 |2024 | | |Hypodermic Needles for Single | |Hypodermic Needles for Single | | | |Use – Colour Coding for | |Use - Colour Coding for | | | |Identification | |Identification | | | |(First Revision) | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |2 |IS 18784: 2024 |17 October 2024 |NA |NA | | |Medical Devices — Sleep Apnoea | | | | | |Breathing Therapy — Masks and | | | | | |Application Accessories | | | | | |(ISO 17510: 2015, MOD) | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |3 |IS 18855: 2024 |17 October 2024 |NA |NA | | |ISO/TS 23128: 2019 | | | | | |Medical Devices - Transfusion | | | | | |Set and Blood Bag Compatibility | | | | | |Test Method | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |4 |IS 18857: 2024 |17 October 2024 |NA |NA | | |ISO/TR 22019: 2019 | | | | | |Nanotechnologies — | | | | | |Considerations for Performing | | | | | |Toxicokinetic Studies with | | | | | |Nanomaterials | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |5 |IS 18879 (Part 2): 2024 |17 October 2024 |NA |NA | | |ISO 8536-2: 2023 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 2 Closures for Infusion Bottles | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |6 |IS 18879 (Part 5): 2024 |17 October 2024 |NA |NA | | |ISO 8536-5: 2004 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 5 Burette Infusion Sets for | | | | | |Single Use, Gravity Feed | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |7 |IS 18879 (Part 7): 2024 |17 October 2024 |NA |NA | | |ISO 8536-7: 2009 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 7 Caps Made of Aluminium- | | | | | |Plastics Combinations for Infusion | | | | | |Bottles | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |8 |IS 18879 (Part 9): 2024 |17 October 2024 |NA |NA | | |ISO 8536-9: 2015 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 9 Fluid Lines for Single Use | | | | | |with Pressure Infusion Equipment | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |9 |IS 18879 (Part 10): 2024 |17 October 2024 |NA |NA | | |ISO 8536-10: 2015 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 10 Accessories for Fluid | | | | | |Lines for Single Use with Pressure | | | | | |Infusion Equipment | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |10 |IS 18879 (Part 11): 2024 |17 October 2024 |NA |NA | | |ISO 8536-11: 2015 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 11 Infusion Filters for Single | | | | | |Use with Pressure Infusion | | | | | |Equipment | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |11 |IS 18879 (Part 12): 2024 |17 October 2024 |NA |NA | | |ISO 8536-12: 2021 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 12 Check Valves for Single | | | | | |Use | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |12 |IS 18879 (Part 13): 2024 |17 October 2024 |NA |NA | | |ISO 8536-13: 2016 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 13 Graduated Flow | | | | | |Regulators for Single Use with | | | | | |Fluid Contact | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |13 |IS 18879 (Part 14): 2024 |17 October 2024 |NA |NA | | |ISO 8536-14: 2016 | | | | | |Infusion Equipment for Medical | | | | | |Use | | | | | |Part 14 Clamps and Flow | | | | | |Regulators for Transfusion and | | | | | |Infusion Equipment without Fluid | | | | | |Contact | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ |14 |IS 18919: 2024 |17 October 2024 |NA |NA | | |Ophthalmic Optics and Instruments | | | | | |— Near Reading Charts | | | | | |(ISO 7921: 2024, MOD) | | | | +----+-------------------------------------------------------------------------------------------+-------------------+-----------------------------------------------------------------+------------------+ CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./646/2024-25] 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 JAISWAL Digitally signed by AMIT KUMAR JAISWAL Date: 2024.10.29 21:54:55 +05'30'

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