Home India Bureau of Indian Standards In pursuance of Sub rule 1 of Rule 15 of the Bureau of India...
Date: 11-Dec-2023 Category: Extra Ordinary State: Union Government Country: India

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

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Bureau of Indian Standards (BIS) has notified the establishment and withdrawal of certain Indian Standards. This notification, issued under the Bureau of Indian Standards Rules, 2018, specifies the dates on which new standards are established and the dates on which older standards are withdrawn.

Key Changes

  • IS 17922 (Part 1): 2023/IEC 62366-1:2015 + AMD 1:2020, concerning medical devices and the application of usability engineering, was established on November 23, 2023, and will replace IS/IEC 62366-1:2015 on December 23, 2023.
  • IS 18374: 2023/ISO 23162:2021, concerning basic semen examination, was established on November 23, 2023.
  • IS 18376: 2023/ISO/TR 20416:2020, concerning post-market surveillance for manufacturers of medical devices, was established on November 23, 2023.
  • IS 18436: 2023/ISO 9588:2007, concerning post-coating treatments of iron or steel to reduce the risk of hydrogen embrittlement, was established on November 23, 2023.
  • IS 18463: 2023/ISO 9587:2007, concerning pretreatment of iron or steel to reduce the risk of hydrogen embrittlement, was established on November 23, 2023.

Impact Analysis

Manufacturers of Medical Devices

  • Manufacturers of medical devices should take note of IS 18376: 2023/ISO/TR 20416:2020 regarding post-market surveillance.

Manufacturers of Metallic and Inorganic Coatings

  • Review and update coating processes to align with the new standards established on November 23, 2023.

Laboratories and Testing Facilities

  • Ensure testing procedures and equipment are aligned with the new standards established on November 23, 2023.

General Stakeholders

  • Refer to the Bureau of Indian Standards for detailed information and compliance requirements.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. Indian Standards: A set of standards developed by the Bureau of Indian Standards covering various products, processes, and services. IS 17922 (Part 1): 2023/IEC 62366-1:2015 + AMD 1:2020: Indian Standard concerning medical devices and the application of usability engineering. IS/IEC 62366-1:2015: Previous Indian Standard concerning medical devices and the application of usability engineering, being withdrawn on December 23, 2023. IS 18374: 2023/ISO 23162:2021: Indian Standard concerning basic semen examination. IS 18376: 2023/ISO/TR 20416:2020: Indian Standard concerning post-market surveillance for manufacturers of medical devices. IS 18436: 2023/ISO 9588:2007: Indian Standard concerning post-coating treatments of iron or steel to reduce the risk of hydrogen embrittlement. IS 18463: 2023/ISO 9587:2007: Indian Standard concerning pretreatment of iron or steel to reduce the risk of hydrogen embrittlement. Bureau of Indian Standards Rules, 2018: The regulatory framework under which the Bureau of Indian Standards operates.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-12122023-250598 xxxGIDHxxx CG-DL-E-12122023-250598 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 826] नई दिल्ली, सोमिार, दिसम्बर 11, 2023/अग्रहायण 20, 1945 No. 826] NEW DELHI, MONDAY, DECEMBER 11, 2023/AGRAHAYANA 20, 1945 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल े जिभाग) अजधसचू ना नई दिल्ली, 28 निम्बर 2023 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (750)—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के जििरण इसम ें संलग्न अनूसूची के जद्वतीय स्ट्तंभ म ें दिय े गय े ह,ैं तीसरे स्ट्तभं म ें इंजगत जतजि को स्ट्िाजपत हो गय े ह|ैं चौिे स्ट्तंभ म ें दिय े गय े मानकों के जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचि ें स्ट्तंभ म ें इंजगत जतजि को िापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस जलए िापस होन े की स.ं िर् भ तिा िीर्कभ िान े ह,ैं की सख्ं या, िर् भतिा जतजि िीर्कभ (1) (2) (3) (4) (5) आई एस 17922 (भाग 1) : 23 निम्बर आई एस/आई ई सी 62366-1 : 23 दिसम्बर 1 2023/आई ई सी 62366-1 : 2015 + 2023 2015 2023 ए एम डी 1 : 2020 जचदकत्सा उपकरण जचदकत्सा उपकरण भाग 1 जचदकत्सा उपकरणों के जलए 7657 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] भाग 1 प्रयोज्य अजभयांजिकी का प्रयोज्य इंिीजनयररंग का अनुप्रयोग अनुप्रयोग (पहला पुनरीक्षण) आई एस 18374 : 2023/आई एस ओ 23 निम्बर लाग ू नहीं लाग ू नहीं 2 23162 : 2021 2023 सामान्य िीय भ परीक्षण — जिजिजि और परीक्षण पद्धजतयााँ आई एस 18376 : 2023/आई एस 23 निम्बर लाग ू नहीं लाग ू नहीं 3 ओ/टी आर 20416 : 2020 2023 जचदकत्सा उपकरण — जनमाभताओं के जलए बािार के बाि की जनगरानी आई एस 18436 : 2023/आई एस ओ 23 निम्बर लाग ू नहीं लाग ू नहीं 4 9588 : 2007 2023 धाजत्िक और अन्य अकाबभजनक कोरटंग्स — हाइड्रोिन उत्सिभन के िोजखम को कम करन े के जलए लोह े या स्ट्टील का पोस्ट्ट-कोरटंग उपचार आई एस 18463 : 2023/आई एस ओ 23 निम्बर लाग ू नहीं लाग ू नहीं 5 9587 : 2007 2023 धाजत्िक और अन्य अकाबभजनक कोरटंग्स — हाइड्रोिन उत्सिभन के िोजखम को कम करन े के जलए लोह े या स्ट्टील का पूिोपचार पी. रािेि, िैज्ञाजनक एफ एि ंउपमहाजनिेिक (आई टी एस, पी आर टी एिं टी एन एम) [जिज्ञापन-III/4/असा./608/2023-24] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 28th November, 2023 Ref: HQ-PUB013/1/2020-PUB-BIS (750)—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. 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 17922 (Part 1) : 2023/IEC 62366-1 : 23 November IS/IEC 62366-1 : 2015 23 December 2023 2015 + AMD 1 : 2020 2023 Medical Devices Medical Devices Part 1 Application of Part 1 Application of Usability Usability Engineering to Engineering Medical Devices[भाग III—खण् ड 4] भारत का रािपि : असाधारण 3 (First Revision) 2 IS 18374 : 2023/ISO 23162 : 2021 23 November NA NA Basic Semen Examination — 2023 Specification and Test Methods 3 IS 18376 : 2023/ISO/TR 20416 : 2020 NA NA Medical Devices — Post-Market 23 November Surveillance for Manufacturers 2023 4 IS 18436 : 2023/ISO 9588 : 2007 23 November NA NA Metallic and Other Inorganic Coatings 2023 — Post-Coating Treatments of Iron or Steel to Reduce the Risk of Hydrogen Embrittlement 5 IS 18463 : 2023/ISO 9587 : 2007 23 November NA NA Metallic and Other Inorganic Coatings 2023 — Pretreatment of Iron or Steel to Reduce the Risk of Hydrogen Embrittlement P. RAJESH, Scientist F & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./608/2023-24] 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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