Home India Bureau of Indian Standards In pursuance of Sub rule 1 of Rule 15 of the Bureau of India...
Date: 29-Oct-2024 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, particulars of which

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • This gazette notification from the Bureau of Indian Standards (BIS) announces the establishment of new Indian Standards and the concurrent validity of some existing standards until their withdrawal.
  • The notification specifies the effective dates for the new standards and the withdrawal dates for the older standards, if any.
  • The standards primarily relate to health informatics, medical devices, and healthcare procedures.

Key Changes

  • Ten new Indian Standards (IS) have been established, with effect from October 8, 2024.
  • IS/ISO/IEEE 11073-10407:2022 replaces IS/ISO/IEEE 11073-10407:2010 for health informatics device interoperability, with the older standard being withdrawn on April 8, 2025.
  • IS 17767:2024 replaces IS 17767:2022 and ISO/TS 17251:2023 replaces ISO/TS 17251:2016 for health informatics related to structured dose information, with the older standards being withdrawn on April 8, 2025.
  • The other eight new standards (IS 18737:2024, IS 18757:2024, IS 18766 (Part 2):2024, IS 18772 (Part 2/Sec 87):2024, IS 18777:2024, IS 18785:2024, IS 18863 (Part 3):2024, and IS 18871:2024) do not have any existing standards being withdrawn and are effective from October 8, 2024.

Impact Analysis

Healthcare Industry

  • Action Item: Conduct a gap analysis to identify areas of non-compliance and develop a plan to meet the new requirements.

Medical Device Manufacturers

  • Action Item: Review and update product design and manufacturing processes to comply with the new standards. Seek necessary certifications.

Regulatory Bodies

  • Action Item: Develop and implement a plan for monitoring and enforcing the new standards.

Patients

  • Action Item: No direct action required but awareness of these changes is important.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and implementing Indian Standards. Indian Standards (IS): Technical standards developed by BIS to ensure quality, safety, and interoperability of products and services. IS/ISO/IEEE 11073-10407: Indian standard for Health Informatics — Device Interoperability. IS 17767: Indian standard for Health Informatics — Business Requirements for a Syntax to Exchange Structured Dose Information for Medicinal Products. ISO/TS 17251: International standard for Health Informatics — Business Requirements for a Syntax to Exchange Structured Dose Information for Medicinal Products. IS 18737: Indian standard for Protocol for Medico-Legal Examination of Accused of Sexual Assault. IS 18757: Indian standard for Protocol for Medico-Legal Examination of Survivor of Sexual Assault. IS 18766 (Part 2): Indian standard for Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications. ISO 18562-2: International standard for Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications. IS 18772 (Part 2/Sec 87): Indian standard for Medical Electrical Equipment — Particular Requirements for Basic Safety and Essential Performance. ISO 80601-2-87: International standard for Medical Electrical Equipment — Particular Requirements for Basic Safety and Essential Performance. IS 18777: Indian standard for Dentistry — Vocabulary of Process Chain from Dental CT to CAD/CAM for Implant Prosthetic Restorations. ISO/TR 22710: International standard for Dentistry — Vocabulary of Process Chain from Dental CT to CAD/CAM for Implant Prosthetic Restorations. IS 18785: Indian standard for Anaesthetic and Respiratory Equipment — Low-Flow Nasal Cannulae for Oxygen Therapy. ISO 23368: International standard for Anaesthetic and Respiratory Equipment — Low-Flow Nasal Cannulae for Oxygen Therapy. IS 18863 (Part 3): Indian standard for Sterilization of Health Care Products — Microbiological Methods. ISO 11737-3: International standard for Sterilization of Health Care Products — Microbiological Methods. IS 18871: Indian standard for Medical Devices — Non-Electrically Driven Portable Infusion Devices. ISO 28620: International standard for Medical Devices — Non-Electrically Driven Portable Infusion Devices.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-29102024-258319 xxxGIDHxxx CG-DL-E-29102024-258319 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 878] नई दिल्ली, मगं लिार, अक्त बू र 29, 2024/कार्तकभ 7, 1946 No. 878] NEW DELHI, TUESDAY, OCTOBER 29, 2024/KARTIKA 7, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल े जिभाग) अजधसचू ना नई दिल्ली, 16 अक् तूबर, 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1073.—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 इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गये ह,ैं तीसरे स्ट्तभं में इंजगत जतजि को स्ट्िाजपत हो गये हैं| चौिे स्ट्तंभ में दिय े गय े मानकों के जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचिें स्ट्तंभ म ें इंजगत जतजि को िापस जलए िान े ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं जतजि िर् भतिा िीर्कभ िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ (1) (2) (3) (4) (5) 08 अप्रैल 2025 1 आई एस/आई एस ओ/आई ई ई ई 08 अक् तूबर 2024 आई एस/आई एस ओ/आई ई ई ई 11073-10407 : 2022 11073-10407 : 2010 7020 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं जतजि िर् भतिा िीर्कभ िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ (1) (2) (3) (4) (5) स्ट्िास्ट््य सूचना जिज्ञान — उपकरण स्ट्िास्ट््य सूचना जिज्ञान — इंटरऑपरेजबजलटी भाग 10407 उपकरण इंटरऑपरेजबजलटी भाग जनिी स्ट्िास्ट््य उपकरण संचार — 10407 जनिी स्ट्िास्ट््य उपकरण उपकरण जििेर्ज्ञता — ब्लड प्रेिर संचार — उपकरण जििेर्ज्ञता — मॉनीटर ब्लड प्रेिर मॉनीटर (पहला पुनरीक्षण) 08 अक् तूबर 2024 08 अप्रैल 2025 2 आई एस 17767 : 2024 आई एस 17767 : 2022 आई एस ओ/टी एस 17251 : 2023 आई एस ओ/टी एस 17251 : स्ट्िास्ट््य सूचना जिज्ञान — और्धीय 2016 उत्पािों के जलए संरजचत खुराक की स्ट्िास्ट््य सूचना जिज्ञान — िानकारी का आिान-प्रिान करने के और्धीय उत्पािों के जलए संरजचत जलए एक िाक्यजिन्यास के जलए खुराक की िानकारी का आिान- व्यािसाजयक अपेक्षाएाँ (पहला प्रिान करने के जलए एक पुनरीक्षण) िाक्यजिन्यास के जलए व्यािसाजयक आिश्यकताएाँ 08 अक् तूबर 2024 लागू नहीं लागू नहीं 3 आई एस 18737 : 2024 यौन उत्पीड़न मामले के आरोपी की जचदकत्सीय कानूनी िााँच के जलए प्रोटोकॉल (मानक संचालन प्रदक्रया) 08 अक् तूबर 2024 लागू नहीं लागू नहीं 4 आई एस 18757 : 2024 यौन उत्पीड़न के उत्तरिीिी की जचदकत्सीय कानूनी िााँच के जलए प्रोटोकॉल (मानक संचालन प्रदक्रया) 08 अक् तूबर 2024 लागू नहीं लागू नहीं 5 आई एस 18766 (भाग 2) : 2024 आई एस ओ 18562-2 : 2024 स्ट्िास्ट््य िेखभाल अनुप्रयोगों में श्वास गैस मागों की िैि अनुकूलता मूल्यांकन भाग 2 कण पिािभ के उत्सिभन के जलए परीक्षण 08 अक् तूबर 2024 लागू नहीं लागू नहीं 6 आई एस 18772 (भाग 2/अनुभाग 87) : 2024 जचदकत्सा जिद्युत उपकरण भाग 2 बुजनयािी सुरक्षा और आिश्यक प्रििभन के जलए जििेर् अपेक्षाएाँ अनुभाग 87 हाई फ्रीक्वेंसी िेंटटलेटर[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं जतजि िर् भतिा िीर्कभ िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ (1) (2) (3) (4) (5) (ISO 80601-2-87 : 2021, संिोजधत) 08 अक् तूबर 2024 लागू नहीं लागू नहीं 7 आई एस 18777 : 2024 आई एस ओ/टी आर 22710 : 2019 िंत जचदकत्सा — प्रत्यारोपण कृजत्रम पुनस्ट्िाभपन के जलए िंत सीटी से सीएडी/सीएएम तक प्रदक्रया श्ृंखला की िब्िािली — जडजिटल प्रोसेस चैन में बैकिडभ प्लाननंग 08 अक् तूबर 2024 लागू नहीं लागू नहीं 8 आई एस 18785 : 2024 आई एस ओ 23368 : 2022 एनेस्ट्िेटटक और श्वसन उपकरण — ऑक्सीिन िेरेपी के जलए लौ-फ्लो नेसल कैनुला 08 अक् तूबर 2024 लागू नहीं लागू नहीं 9 आई एस 18863 (भाग 3) : 2024 आई एस ओ 11737-3 : 2023 स्ट्िास्ट््य िेखभाल उत्पािों का जिसंक्रमण — सूक्ष्मिैजिकीय पद्धजतयााँ भाग 3 बैक्टीटरयल एंडोटॉजक्सन परीक्षण 08 अक् तूबर 2024 लागू नहीं लागू नहीं 10 आई एस 18871 : 2024 आई एस ओ 28620 : 2020 जचदकत्सा उपकरण — गैर-जिद्युत चाजलत पोटेबल इन्फ्यूिन उपकरण जचत्रा गुप्ता, िैज्ञाजनक िी एि ं उप महाजनिेिक (हॉलमार्किंग) [जिज्ञापन-III/4/असा./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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] 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) IS/ISO/IEEE 11073-10407 : IS/ISO/IEEE 11073-10407 : 2022 08 October 2024 2010 08 April 2025 Health Informatics — Device Health Informatics — Device Interoperability Interoperability 1 Part 10407 Personal Health Part 10407 Personal Health Device Communication — Device Device Communication — Specialization — Blood Pressure Device Specialization — Blood Monitor Pressure Monitor (First Revision) 08 October 2024 IS 17767 : 2022 IS 17767 : 2024 08 April 2025 ISO/TS 17251 : 2016 ISO/TS 17251 : 2023 Health Informatics — Business Health Informatics — Business 2 Requirements for a Syntax to Requirements for a Syntax to Exchange Structured Dose Exchange Structured Dose Information for Medicinal Information for Medicinal Products Products (First Revision) 08 October 2024 IS 18737 : 2024 NA NA Protocol for Medico-Legal 3 Examination of Accused of Sexual Assault (Standard Operating Procedure) 08 October 2024 NA NA IS 18757 : 2024 4 Protocol for Medico-Legal Examination of Survivor of Sexual Assault (Standard Operating Procedure) 08 October 2024 IS 18766 (Part 2) : 2024 NA NA ISO 18562-2 : 2024 Biocompatibility Evaluation of 5 Breathing Gas Pathways in Healthcare Applications Part 2 Tests for Emissions of Particulate Matter 08 October 2024 IS 18772 (Part 2/Sec 87) : 2024 NA NA Medical Electrical Equipment Part 2 Particular Requirements for 6 Basic Safety and Essential Performance Section 87 High Frequency Ventilators (ISO 80601-2-87 : 2021, MOD) 08 October 2024 NA NA IS 18777 : 2024 ISO/TR 22710 : 2019 7 Dentistry — Vocabulary of Process Chain from Dental CT to CAD/CAM for Implant Prosthetic Restorations — Backward[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5 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) Planning in the Digital Process Chain 08 October 2024 IS 18785 : 2024 NA NA ISO 23368 : 2022 8 Anaesthetic and Respiratory Equipment — Low-Flow Nasal Cannulae for Oxygen Therapy 08 October 2024 IS 18863 (Part 3) : 2024 NA NA ISO 11737-3 : 2023 9 Sterilization of Health Care Products — Microbiological Methods Part 3 Bacterial Endotoxin Testing 08 October 2024 IS 18871 : 2024 NA NA ISO 28620 : 2020 10 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.

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