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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

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 ten new Indian Standards (IS) related to medical devices and healthcare products.
  • These new standards are based on existing international standards (ISO) and will be effective from October 17, 2024.

Key Changes

  • Ten new Indian Standards (IS) have been established, numbered IS 18805:2024, IS 18866:2024, IS 18867 (Part 1):2024, IS 18868:2024, IS 18870:2024, IS 18872:2024, IS 18880:2024, IS 18881 (Part 4):2024, IS 18881 (Part 6):2024 and IS 18881 (Part 7):2024.
  • These standards are based on corresponding ISO standards, such as ISO 5359:2014, ISO 9626:2016, ISO 22077-1:2022, ISO/TS 17988:2020, ISO/TS 20746:2016, ISO 21881:2019, ISO 13004:2022, ISO 13408-4:2005, ISO 13408-6:2021, and ISO 13408-7:2012 respectively.
  • The new IS standards cover various aspects of medical devices and healthcare products, including anaesthetic and respiratory equipment, stainless steel needle tubing, health informatics, dental materials, sterile packaging, and sterilization processes.
  • All the new standards are effective from October 17, 2024.
  • The corresponding ISO standards will remain in force concurrently with the newly established Indian standards. There is no mention of any withdrawal date for the ISO standards in this notification.

Impact Analysis

Medical Device Manufacturers

  • This will likely involve additional costs for testing, validation, and potentially re-designing of products.

Healthcare Providers

  • They need to be aware of the new standards when procuring medical devices and related products.

Regulatory Bodies

  • They may need to conduct audits and inspections to ensure compliance by manufacturers and healthcare providers.

Consumers

  • This will lead to better healthcare outcomes and reduced risks associated with medical procedures and treatments.

Action Items

  • Regulatory bodies should update their guidelines and procedures to reflect the new standards and ensure compliance through appropriate monitoring mechanisms.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and implementing Indian Standards. Indian Standards (IS): National standards developed by BIS for various products and services in India. International Organization for Standardization (ISO): An international standard-setting body composed of representatives from various national standards organizations. Bureau of Indian Standards Rules, 2018: The rules governing the functioning of the Bureau of Indian Standards.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-29102024-258316 xxxGIDExxx CG-DL-E-29102024-258316 असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 875] नई दिल्ली, मगं ल ार, अक्त बू र 29, 2024/कार्तकभ 7, 1946 No. 875] NEW DELHI, TUESDAY, OCTOBER 29, 2024/KARTIKA 7, 1946 भारतीय मानक ब्य ूरो (उपभोक्त ा मामल ेज भाग) अजधसचू ना नई दिल्ली, 21 अक् तूबर, 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1070).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के ज रण इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गये हैं, तीसरे स्ट्तंभ में इंजगत जतजि को स्ट्िाजपत हो गये ह|ैं चौिे स्ट्तंभ में दिये गये मानकों के ज रण, यदि कोई हो तो े भी साि-साि लागू रहेंगे िब तक े पााँच ें स्ट्तंभ में इंजगत जतजि को ापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, र् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि ापस जलए ापस होन ेकी जतजि स.ं तिा िीर्भक िान ेह,ैं की सख्ं या, र् भतिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 18805 : 2024 17 अक्टूबर 2024 लागू नहीं लागू नहीं आई एस ओ 5359 : 2014 7017 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, र् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि ापस जलए ापस होन ेकी जतजि स.ं तिा िीर्भक िान ेह,ैं की सख्ं या, र् भतिा िीर्कभ (1) (2) (3) (4) (5) + ए एम डी 1 : 2017 एनेस्ट्िेटटक और श्वसन उपकरण — जचदकत्सा गैसों के उपयोग के जलए लो-प्रेिर होस असेंबली 17 अक्टूबर 2024 लागू नहीं 2 आई एस 18866 : 2024 लागू नहीं आई एस ओ 9626 : 2016 जचदकत्सा उपकरणों के जनमाभण के जलए स्ट्टेनलेस स्ट्टील सुई ट्यूबबंग — अपेक्षाएाँ और परीक्षण पद्धजतया ाँ 17 अक्टूबर 2024 लागू नहीं 3 आई एस 18867 (भाग 1) : 2024 लागू नहीं आई एस ओ 22077-1 : 2022 स्ट् ास्ट््य सूचना ज ज्ञान — जचदकत्सा तरंग प्रारूप भाग 1 एन्कोबडंग जनयम 17 अक्टूबर 2024 लागू नहीं 4 आई एस 18868 : 2024 लागू नहीं आई एस ओ/टी एस 17988 : 2020 ितं जचदकत्सा — ितं जमश्रण के जलए संक्षारण परीक्षण पद्धजतयााँ 17 अक्टूबर 2024 लागू नहीं 5 आई एस 18870 : 2024 लागू नहीं आई एस ओ/टी एस 20746 : 2016 ितं जचदकत्सा — हर््जभयन इंडेंटेिन स्ट्रेंि (एचआईटी) पद्धजत द्वारा ितं जमश्रण की ताकत का जनधाभरण 17 अक्टूबर 2024 लागू नहीं 6 आई एस 18872 : 2024 लागू नहीं आई एस ओ 21881 : 2019 दिबलंग ग्लास कार्ट्रभि के जलए रोगाणुमुक्त तैयार पैकेि[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, र् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि ापस जलए ापस होन ेकी जतजि स.ं तिा िीर्भक िान ेह,ैं की सख्ं या, र् भतिा िीर्कभ (1) (2) (3) (4) (5) 17 अक्टूबर 2024 लागू नहीं 7 आई एस 18880 : 2024 लागू नहीं आई एस ओ 13004 : 2022 स्ट् ास्ट््य िखे भाल उत्पािों का ज संक्रमण — ज दकरण — चयजनत ज संक्रमण खुराक की पुजि: VD SD पद्धजत max 17 अक्टूबर 2024 लागू नहीं 8 आई एस 18881 (भाग 4) : 2024 लागू नहीं आई एस ओ 13408-4 : 2005 स्ट् ास्ट््य िखे भाल उत्पािों का कीटाणु-नािक प्रसंस्ट्करण भाग 4 क्लीन-इन-प्लेस प्रौद्योजगदकयों 17 अक्टूबर 2024 लागू नहीं 9 आई एस 18881 (भाग 6) : 2024 लागू नहीं आई एस ओ 13408-6 : 2021 स्ट् ास्ट््य िखे भाल उत्पािों का कीटाणु-नािक प्रसंस्ट्करण भाग 6 आइसोलेटर प्रणाजलयााँ 17 अक्टूबर 2024 लागू नहीं 10 आई एस 18881 (भाग 7) : 2024 लागू नहीं आई एस ओ 13408-7 : 2012 स्ट् ास्ट््य िखे भाल उत्पािों का कीटाणु-नािक प्रसंस्ट्करण भाग 7 जचदकत्सा उपकरणों और संयोिन उत्पािों के जलए ैकजल्पक प्रदक्रयाएाँ जचत्रा गुप्ता, ैज्ञाजनक िी ए ं उप महाजनििे क (हॉलमार्किंग) [ज ज्ञापन-III/4/असा./645/2024-25]4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 21st October 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1070).—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 Indian Date of No. Standards Established Standards to be Withdrawn, if Withdrawal Establishment any (1) (2) (3) (4) (5) IS 18805 : 2024 17 October 2024 NA NA ISO 5359 : 2014 1 + AMD 1 : 2017 Anaesthetic and Respiratory Equipment — Low-Pressure Hose Assemblies for Use with Medical Gases IS 18866 : 2024 17 October 2024 NA NA ISO 9626 : 2016 2 Stainless Steel Needle Tubing for the Manufacture of Medical Devices — Requirements and Test Methods 17 October 2024 IS 18867 (Part 1) : 2024 NA NA ISO 22077-1 : 2022 3 Health Informatics — Medical Waveform Format Part 1 Encoding Rules 17 October 2024 NA NA IS 18868 : 2024 4 ISO/TS 17988 : 2020 Dentistry — Corrosion Test Methods for Dental Amalgam IS 18870 : 2024 17 October 2024 NA NA ISO/TS 20746 : 2016 5 Dentistry — Determination of the Strength of Dental Amalgam by the Hertzian Indentation Strength (HIT) Method[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5 Sl. No., Year & Title of the Indian Date of No. , Year & Title of the Indian Date of No. Standards Established Standards to be Withdrawn, if Withdrawal Establishment any (1) (2) (3) (4) (5) 17 October 2024 NA NA IS 18872 : 2024 6 ISO 21881 : 2019 Sterile Packaged Ready for Filling Glass Cartridges IS 18880 : 2024 17 October 2024 NA NA ISO 13004 : 2022 7 Sterilization of Health Care Products — Radiation — Substantiation of Selected Sterilization Dose: Method VD SD max IS 18881 (Part 4) : 2024 17 October 2024 NA NA ISO 13408-4 : 2005 8 Aseptic Processing of Health Care Products Part 4 Clean-in-Place Technologies 9 17 October 2024 IS 18881 (Part 6) : 2024 NA NA ISO 13408-6 : 2021 Aseptic Processing of Health Care Products Part 6 Isolator Systems IS 18881 (Part 7) : 2024 17 October 2024 ISO 13408-7 : 2012 NA NA 10 Aseptic Processing of Health Care Products Part 7 Alternative Processes for Medical Devices and Combination Products CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./645/2024-25] 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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