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Core Purpose

Notification by the Bureau of Indian Standards establishing new Indian Standards and specifying withdrawal dates for superseded standards.

Detailed Summary

By notification Ref: HQ-PUB013/1/2020-PUB-BIS (1073) dated 16th October 2024, the Bureau of Indian Standards (Department of Consumer Affairs), in pursuance of sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, notified establishment of Indian Standards effective 8th October 2024, listing corresponding standards being withdrawn effective 8th April 2025 where applicable. Key entries include IS/ISO/IEEE 11073-10407:2022 (Health Informatics - Device Interoperability, Personal Health Device Communication - Blood Pressure Monitor, First Revision), replacing IS/ISO/IEEE 11073-10407:2010; IS 17767:2024 / ISO/TS 17251:2023 (Health Informatics - Business Requirements for Exchange of Structured Dose Information), replacing IS 17767:2022 / ISO/TS 17251:2016; IS 18737:2024 (Protocol for Medico-Legal Examination of Accused of Sexual Assault); IS 18757:2024 (Protocol for Medico-Legal Examination of Survivor of Sexual Assault); IS 18766 (Part 2):2024 / ISO 18562-2:2024 (Biocompatibility Evaluation of Breathing Gas Pathways - Particulate Matter Emissions); IS 18772 (Part 2/Sec 87):2024 (Medical Electrical Equipment - High Frequency Ventilators, based on ISO 80601-2-87:2021, MOD); IS 18777:2024 / ISO/TR 22710:2019 (Dentistry - Process Chain from Dental CT to CAD/CAM Implant Prosthetic Restorations); "Planning in the Digital Process Chain"; IS 18863 (Part 3):2024 / ISO 11737-3:2023 (Sterilization of Health Care Products - Bacterial Endotoxin Testing); and IS 18871:2024 / ISO 28620:2020 (Non-Electrically Driven Portable Infusion Devices), the latter group having no prior standard withdrawn. The notification bears file number ADVT.-III/4/Exty./648/2024-25 and is signed by Chitra Gupta, Scientist G & DDG (Hallmarking).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-29102024-258319 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 878| NEW DELHI, TUESDAY, OCTOBER 29, 2024/KARTIKA 7, 1946 [ADVT.-III/4/Exty./648/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 16th October, 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1073).—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 | Date of | | No. | Standards Established | Establishment | Indian Standards to be | Withdrawal | | | | | Withdrawn, if any | | +=====+=============================================+===================+=============================================+================+ | (1) | (2) | (3) | (4) | (5) | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 1 | IS/ISO/IEEE 11073-10407 : 2022 | 08 October 2024 | IS/ISO/IEEE 11073-10407 : | 08 April 2025 | | | Health Informatics – Device | | 2010 | | | | Interoperability | | Health Informatics – Device | | | | Part 10407 Personal Health | | Interoperability | | | | Device Communication – Device | | Part 10407 Personal Health | | | | Specialization – Blood Pressure | | Device Communication – | | | | Monitor | | Device Specialization – Blood | | | | (First Revision) | | Pressure Monitor | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 2 | IS 17767: 2024 | 08 October 2024 | IS 17767: 2022 | 08 April 2025 | | | ISO/TS 17251 : 2023 | | ISO/TS 17251: 2016 | | | | Health Informatics – Business | | Health Informatics – Business | | | | Requirements for a Syntax to | | Requirements for a Syntax to | | | | Exchange Structured Dose | | Exchange Structured Dose | | | | Information for Medicinal | | Information for Medicinal | | | | Products (First Revision) | | Products | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 3 | IS 18737: 2024 | 08 October 2024 | NA | NA | | | Protocol for Medico-Legal | | | | | | Examination of Accused of Sexual | | | | | | Assault (Standard Operating | | | | | | Procedure) | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 4 | IS 18757: 2024 | 08 October 2024 | NA | NA | | | Protocol for Medico-Legal | | | | | | Examination of Survivor of Sexual | | | | | | Assault (Standard Operating | | | | | | Procedure) | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 5 | IS 18766 (Part 2): 2024 | 08 October 2024 | NA | NA | | | ISO 18562-2: 2024 | | | | | | Biocompatibility Evaluation of | | | | | | Breathing Gas Pathways in | | | | | | Healthcare Applications | | | | | | Part 2 Tests for Emissions of | | | | | | Particulate Matter | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 6 | IS 18772 (Part 2/Sec 87): 2024 | 08 October 2024 | NA | NA | | | Medical Electrical Equipment | | | | | | Part 2 Particular Requirements for | | | | | | Basic Safety and Essential | | | | | | Performance | | | | | | Section 87 High Frequency | | | | | | Ventilators | | | | | | (ISO 80601-2-87 : 2021, MOD) | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 7 | IS 18777: 2024 | 08 October 2024 | NA | NA | | | ISO/TR 22710: 2019 | | | | | | Dentistry — Vocabulary of | | | | | | Process Chain from Dental CT to | | | | | | CAD/CAM for Implant Prosthetic | | | | | | Restorations — Backward | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 8 | Planning in the Digital Process | 08 October 2024 | NA | NA | | | Chain | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 9 | IS 18863 (Part 3): 2024 | 08 October 2024 | NA | NA | | | ISO 11737-3: 2023 | | | | | | Sterilization of Health Care | | | | | | Products — Microbiological | | | | | | Methods | | | | | | Part 3 Bacterial Endotoxin Testing | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ | 10 | IS 18871: 2024 | 08 October 2024 | NA | NA | | | ISO 28620: 2020 | | | | | | Medical Devices — Non- | | | | | | Electrically Driven Portable | | | | | | Infusion Devices | | | | +-----+---------------------------------------------+-------------------+---------------------------------------------+----------------+ CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./648/2024-25] 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 KUMAR JAISWAL Date: 2024.10.29 21:50:24+05'30'

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