Home India Bureau of Indian Standards In pursuance of Sub rule (1) of Rule (15) of the Bureau of I...
Date: 20-Dec-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 issued by the Bureau of Indian Standards (BIS) announces the establishment of new Indian Standards and the withdrawal of an existing standard. The notification is in pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018.
  • The notification lists 15 Indian Standards, specifying their establishment date and, where applicable, the standards they replace and the date of withdrawal of the replaced standards. Most of the new standards are related to medical devices, healthcare products, and terminology.

Key Changes

  • A total of 15 new Indian Standards have been established on December 13, 2024.
  • One standard, IS 1303:2024 (Paints - Glossary of Terms), replaces IS 1303:1983 and IS 6667-1972. The older standards will be withdrawn on June 13, 2025.
  • The remaining 14 new standards do not replace any existing Indian standards and are effective from December 13, 2024.
  • These new standards cover various areas including: In-vitro Diagnostic devices (blood gas analyzers), Unani medicine terminology, Dentistry (brazing materials, tooth development stages), Ophthalmic optics (contact lenses), Medical infusion equipment, Aseptic processing of healthcare products, and containers for homeopathic medicines.

Impact Analysis

Manufacturers of Paints

  • They should ensure that their products and labeling align with the updated definitions.

Manufacturers of Medical Devices and Healthcare Products

  • Manufacturers should conduct thorough reviews of their existing products and processes to identify any gaps in compliance and take corrective actions.

Healthcare Providers

  • Healthcare providers should update their procurement policies and procedures to prioritize products that meet the latest BIS standards.

Homoeopathic Medicine Manufacturers

  • This may necessitate changes in packaging materials and processes to adhere to the new specifications.

Bureau of Indian Standards (BIS)

  • BIS should also provide guidance and support to businesses to facilitate their transition to the new standards.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting Indian Standards. Indian Standards: The technical standards developed and published by BIS, which specify the requirements for products, processes, and services. IS 1303:2024: Indian Standard for Paints - Glossary of Terms (Third Revision), replacing IS 1303:1983 and IS 6667-1972. IS 17716:2024: Indian Standard for In-vitro Diagnostic (IVD) Device — Blood Gas Analyzers. IS 18750 (Part 4): 2024: Indian Standard for Unani Medicine — Glossary of Terms Part 4 Standardized Terminology Used for Ear, Nose and Throat Diseases. IS 18750 (Part 5): 2024: Indian Standard for Unani Medicine — Glossary of Terms Part 5 Standardized Terminology Used for Cardiovascular Diseases. IS 18750 (Part 6): 2024: Indian Standard for Unani Medicine — Glossary of Terms Part 6 Standardized Terminology Used for Respiratory System Diseases. IS 18803:2024: Indian Standard for Dentistry — Brazing Materials. IS 18853:2024: Indian Standard for Ophthalmic Optics — Contact Lenses and Contact Lens Care Products Labelling. IS 18879 (Part 3): 2024: Indian Standard for Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles. IS 18879 (Part 6): 2024: Indian Standard for Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles. IS 18879 (Part 8): 2024: Indian Standard for Infusion Equipment for Medical Use Part 8 Infusion Sets for Single Use with Pressure Infusion Apparatus. IS 18879 (Part 15): 2024: Indian Standard for Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use. IS 18881 (Part 3): 2024: Indian Standard for Aseptic Processing of Health Care Products Part 3 Lyophilization. IS 18967:2024: Indian Standard for Dentistry — Designation System for Tooth Developmental Stages. IS 19084:2024: Indian Standard for Plastic Containers and Closures for Homoeopathic Pharmaceutical Preparations — Specification. IS 19085:2024: Indian Standard for Glass Containers for Homoeopathic Pharmaceutical Preparations — Specification.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 ससससीीीी....जजजजीीीी....----डडडडीीीी....एएएएलललल....----अअअअ....----22223333111122222222000022224444----222255559999555599999999 xxxGIDHxxx CCCCGGGG----DDDDLLLL----EEEE----22223333111122222222000022224444----222255559999555599999999 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 1020] नई दिल्ली, िुक्रिार, दिसम्ब र 20, 2024/अग्रहायण 29, 1946 No. 1020] NEW DELHI, FRIDAY, DECEMBER 20, 2024/AGRAHAYANA 29, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 17 दिसम्बर 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1114)––– भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यरू ो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के जििरण 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 जििरण, यदि कोई हो तो िे भी साि-साि लाग ू रहगें े िब तक िे पाचाँ िें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जतजि िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ जतजि (1) (2) (3) (5) 1 13 दिसम्बर 13 िून 2024 2025 आई एस 1303 : 2024 आई एस 1303 : 1983 8248 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जतजि िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ जतजि (1) (2) (3) (5) पेंट्स — पाररभाजर्क िब्िािली पेंट्स से संबंजधत िब्िािली (तीसरा पुनरीक्षण) (िसू रा पनु रीक्षण) आई एस 6667 – 1972 ससंिेरिक रेजिन उद्योग में प्रयक्तु िब्िों की िब्िािली 2 13 दिसम्बर लाग ूनहीं 2024 आई एस 17716 : 2024 लाग ूनहीं इन-जिरो डायग्नोजस्ट्िक (आईिीडी) उपकरण — ब्लड गैस एनालाइिर 3 13 दिसम्बर लाग ूनहीं 2024 आई एस 18750 (भाग 4) : 2024 लाग ूनहीं यूनानी जचदकत्सा — पाररभाजर्क िब्िािली भाग 4 कान, नाक और गला रोगों के जलए मानकीकृत िब्िािली 4 13 दिसम्बर लाग ूनहीं 2024 आई एस 18750 (भाग 5) : 2024 लाग ूनहीं यूनानी जचदकत्सा — पाररभाजर्क िब्िािली भाग 5 हृिय रोगों के जलए मानकीकृत िब्िािली 5 13 दिसम्बर लाग ूनहीं 2024 आई एस 18750 (भाग 6) : 2024 लाग ूनहीं यूनानी जचदकत्सा — पाररभाजर्क िब्िािली भाग 6 श्वसन तंत्र रोगों के जलए मानकीकृत िब्िािली 6 13 दिसम्बर लाग ूनहीं 2024 आई एस 18803 : 2024 लाग ूनहीं आई एस ओ 9333 : 2022 िंत जचदकत्सा — ब्रेसिंग सामग्री[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जतजि िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ जतजि (1) (2) (3) (5) 7 13 दिसम्बर लाग ूनहीं 2024 आई एस 18853 : 2024 लाग ूनहीं आई एस ओ 11978 : 2017 + ए एम डी 1 : 2020 नेत्र संबंधी प्रकाजिकी — संपकभ लेंस और संपकभ लेंस िेखभाल उत्पाि लेबसलगं 8 13 दिसम्बर लाग ूनहीं 2024 आई एस 18879 (भाग 3) : 2024 लाग ूनहीं आई एस ओ 8536-3 : 2009 + ए एम डी 1 : 2022 जचदकत्सीय उपयोग के जलए इन्फ्यूिन उपकरण भाग 3 इन्फ्यूिन बोतलों के जलए एल्यूमीजनयम कैप 9 13 दिसम्बर लाग ूनहीं 2024 आई एस 18879 (भाग 6) : 2024 लाग ूनहीं आई एस ओ 8536-6 : 2016 जचदकत्सीय उपयोग के जलए इन्फ्यूिन उपकरण भाग 6 इन्फ्यूिन बोतलों के जलए फ़्रीि ड्राइंग क्लोिर 10 13 दिसम्बर लाग ूनहीं 2024 आई एस 18879 (भाग 8) : 2024 लाग ूनहीं आई एस ओ 8536-8 : 2015 जचदकत्सीय उपयोग के जलए इन्फ्यूिन उपकरण भाग 8 िबाि इन्फ्यूिन उपकरण के साि एकल उपयोग के जलए इन्फ्यूिन सेि 11 13 दिसम्बर लाग ूनहीं 2024 आई एस 18879 (भाग 15) : लाग ूनहीं 2024 आई एस ओ 8536-15 : 2022 + ए एम डी 1 : 2023 जचदकत्सीय उपयोग के जलए4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जतजि िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ जतजि (1) (2) (3) (5) इन्फ्यूिन उपकरण भाग 15 एकल उपयोग के जलए प्रकाि-सुरक्षात्मक इन्फ्यूिन सेट्स 12 13 दिसम्बर लाग ूनहीं 2024 आई एस 18881 (भाग 3) : 2024 लाग ूनहीं आई एस ओ 13408-3 : 2006 स्ट्िास्ट््य िेखभाल उत्पािों का कीिाणु-नािक प्रसंस्ट्करण भाग 3 जलयोदिलाइिेिन 13 13 दिसम्बर लाग ूनहीं 2024 आई एस 18967 : 2024 लाग ूनहीं आई एस ओ 5365 : 2024 िंत जचदकत्सा — िांतों के जिकास के चरणों के जलए अजभधान प्रणाली 14 13 दिसम्बर लाग ूनहीं 2024 आई एस 19084 : 2024 लाग ूनहीं होम्योपैजिक और्जधयों के जलए प्लाजस्ट्िक कंिेनर और क्लोिर — जिजिजि 15 13 दिसम्बर लाग ूनहीं 2024 आई एस 19085 : 2024 लाग ूनहीं होम्योपैजिक और्जधयों के जलए ग्लास कंिेनर — जिजिजि जचत्रा गुप् ता, िैज्ञाजनक िी एि ं उप महाजनिेिक (हॉलमार्किंग) [जिज्ञापन-III/4/असा./789/2024-25][भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 5 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 17th December 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1114) 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 Date of No. , Year & Title of the Date of No. Indian Standards Indian Standards to be Withdrawal Establishment Established Withdrawn, if any (1) (2) (3) (4) (5) 13 December 13 June 2025 2024 1 IS 1303 : 2024 IS 1303 : 1983 Paints — Glossary of Terms Glossary of Terms Relating to Paints (Third Revision) (Second Revision) IS 6667 – 1972 Glossary of Terms Used in Synthetic Resin Industry 13 December NA 2024 2 IS 17716 : 2024 NA In-vitro Diagnostic (IVD) Device — Blood Gas Analyzers 13 December NA 2024 3 IS 18750 (Part 4) : 2024 NA Unani Medicine — Glossary of Terms Part 4 Standardized Terminology Used for Ear, Nose and Throat Diseases 13 December NA 2024 4 IS 18750 (Part 5) : 2024 NA Unani Medicine — Glossary6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] Sl No., Year & Title of the Date of No. , Year & Title of the Date of No. Indian Standards Indian Standards to be Withdrawal Establishment Established Withdrawn, if any (1) (2) (3) (4) (5) of Terms Part 5 Standardized Terminology Used for Cardiovascular Diseases 13 December NA 2024 5 IS 18750 (Part 6) : 2024 NA Unani Medicine — Glossary of Terms Part 6 Standardized Terminology Used for Respiratory System Diseases 13 December NA 2024 6 IS 18803 : 2024 NA ISO 9333 : 2022 Dentistry — Brazing Materials 13 December NA 2024 7 IS 18853 : 2024 NA ISO 11978 : 2017 + AMD 1 : 2020 Ophthalmic Optics — Contact Lenses and Contact Lens Care Products Labelling 13 December NA 2024 8 IS 18879 (Part 3) : 2024 NA ISO 8536-3 : 2009 + AMD 1 : 2022 Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles 13 December NA 2024 9 IS 18879 (Part 6) : 2024 NA ISO 8536-6 : 2016 Infusion Equipment for[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 7 Sl No., Year & Title of the Date of No. , Year & Title of the Date of No. Indian Standards Indian Standards to be Withdrawal Establishment Established Withdrawn, if any (1) (2) (3) (4) (5) Medical Use Part 6 Freeze Drying Closures for Infusion Bottles 13 December NA 2024 10 IS 18879 (Part 8) : 2024 NA ISO 8536-8 : 2015 Infusion Equipment for Medical Use Part 8 Infusion Sets for Single Use with Pressure Infusion Apparatus 13 December NA 2024 11 IS 18879 (Part 15) : 2024 NA ISO 8536-15 : 2022 + AMD 1 : 2023 Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use 13 December NA 2024 12 IS 18881 (Part 3) : 2024 NA ISO 13408-3 : 2006 Aseptic Processing of Health Care Products Part 3 Lyophilization 13 December NA 2024 13 IS 18967 : 2024 NA ISO 5365 : 2024 Dentistry — Designation System for Tooth Developmental Stages 13 December NA 2024 14 IS 19084 : 2024 NA Plastic Containers and Closures for Homoeopathic Pharmaceutical Preparations — Specification 13 December NA 2024 15 IS 19085 : 2024 NA8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] Sl No., Year & Title of the Date of No. , Year & Title of the Date of No. Indian Standards Indian Standards to be Withdrawal Establishment Established Withdrawn, if any (1) (2) (3) (4) (5) Glass Containers for Homoeopathic Pharmaceutical Preparations — Specification CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./789/2024-25] 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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