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Date: 20-Jun-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

Gazette Notification Overview

  • The gazette notification issued by the Bureau of Indian Standards (BIS), Department of Consumer Affairs, announces the establishment of new Indian Standards and the concurrent withdrawal of older standards.
  • This notification is in pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018.

Key Changes

  • The notification establishes 10 new Indian Standards across various categories including Thoracic Surgery Instruments, Veterinary Surgical Instruments, and Ophthalmic Implants.
  • The new standards (IS 7346:2024, IS 7382:2024, IS 10937:2024, IS 10938:2024, IS 10955:2024, IS 11566:2024, IS 12329:2024, IS 12344:2024, IS 18614:2024, IS 18639:2024) were established on June 6, 2024.
  • The older standards (IS 7346-1987, IS 7382-1987, IS 10937-1984, IS 10938-1984, IS 10955-1984, IS 11566-1986, IS 12329-1988, IS 12344-1988, IS/ISO 16672:2015, IS/ISO 15798:2013) will be withdrawn on September 6, 2024.
  • The standards being replaced relate to specifications for surgical instruments and ophthalmic implants.

Impact Analysis

Manufacturers of Surgical Instruments and Ophthalmic Implants

  • Action Items: Discontinue production of items compliant with the older standards (IS 7346-1987, IS 7382-1987, IS 10937-1984, IS 10938-1984, IS 10955-1984, IS 11566-1986, IS 12329-1988, IS 12344-1988, IS/ISO 16672:2015, IS/ISO 15798:2013) by September 6, 2024.

Hospitals and Healthcare Providers

  • Action Items: Train medical staff on the updated specifications and usage of instruments compliant with the new standards.

Bureau of Indian Standards (BIS)

  • Action Items: Provide necessary guidance and support to manufacturers to facilitate the transition to the new standards.

Consumers/Patients

  • Action Items: Increased awareness regarding the standards will ensure better healthcare outcomes.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards for goods and services. Department of Consumer Affairs: The government department under which the Bureau of Indian Standards operates. Indian Standards: A set of specifications and guidelines developed by the Bureau of Indian Standards to ensure quality, safety, and reliability of products and services. Bureau of Indian Standards Rules, 2018: The set of rules governing the operations and functions of the Bureau of Indian Standards.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-21062024-254847 xxxGIDHxxx CG-DL-E-21062024-254847 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 428] नई दिल्ली, बहृ स्ट्पजतिार, िनू 20, 2024/ज्य ष्े ठ 30, 1946 No. 428] NEW DELHI, THURSDAY, JUNE 20, 2024/JYAISHTHA 30, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 11 िून, 2024 सिं भ:भ HQ-PUB012/4/2020-PUB-BIS (899)—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 ह|ैं चौिे स्ट्तंभ में दिय े गय े मानकों के जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचि ें स्ट्तंभ में 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.ं जतजि िर् भतिा िीर्कभ िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 7346 : 2024 6 िून 2024 आई एस 7346 - 1987 6 जसतम्बर 2024 3654 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] िक्ष िल्य जचदकत्सा उपकरण — पसली रास्ट्पेटरीज़, ररब, सेम्ब के स्ट्िरूप सुधारक — जिजिजि के जलए जिजिजि (िसू रा पनु रीक्षण) (पहला पुनरीक्षण) 6 िून 2024 6 जसतम्बर 2 आई एस 7382 : 2024 आई एस 7382 - 1987 2024 िक्ष िल्य जचदकत्सा उपकरण — पसली कतभक, ररब, प्राइस िॉमस स्ट्िरूप कतभक, िॉमस स्ट्िरूप — जिजिजि के जलए जिजिजि (िसू रा पनु रीक्षण) (पहला पनु रीक्षण) 6 िून 2024 6 जसतम्बर 3 आई एस 10937 : 2024 आई एस 10937 - 1984 2024 बैल के नाक की ररंग और कुंिी — नाक की ररंग और कुंिी, बलै के जिजिजि जलए जिजिजि (पहला पुनरीक्षण) 4 आई एस 10938 : 2024 6 िून 2024 आई एस 10938 - 1984 6 जसतम्बर 2024 हत्िे और म्यान के साि िोधारी िोधक िोधक, िोधारी के साि हत्ि ेऔर — जिजिजि म्यान के जलए जिजिजि (पहला पुनरीक्षण) 5 आई एस 10955 : 2024 6 िून 2024 आई एस 10955 - 1984 6 जसतम्बर 2024 पिु जचदकत्सा सर्िभकल उपकरण — िल्यदक्रया जिद्रक के जलए जिजिजि िल्यदक्रया जिद्रक — जिजिजि (पहला पुनरीक्षण) 6 िून 2024 6 जसतम्बर 6 आई एस 11566 : 2024 आई एस 11566 - 1986 2024 िक्ष िल्य जचदकत्सा उपकरण — कपारटका प्रजतकर्भक के जलए कपारटका प्रजतकर्भक — जिजिजि जिजिजि (पहला पुनरीक्षण) 7 आई एस 12329 : 2024 6 िून 2024 आई एस 12329 - 1988 6 जसतम्बर 2024 पिु जचदकत्सा सर्िभकल उपकरण — स्ट्ि-केंदद्रत हड्डी पकड़ने का संििं के स्ट्ि-केंदद्रत हड्डी पकड़ने का संििं — जलए जिजिजि जिजिजि (पहला पुनरीक्षण) 8 आई एस 12344 : 2024 6 िून 2024 आई एस 12344 - 1988 6 जसतम्बर 2024 पि ु जचदकत्सा सर्िभकल उपकरण — िंटनी संिंि के जलए जिजिजि िंटनी संिंि — जिजिजि (पहला पुनरीक्षण) 6 िून 2024 9 आई एस 18614 : 2024 आई एस/आई एस ओ 16672 : 6 जसतम्बर 2024 नेत्र प्रत्यारोपण — ऑक्यलु र 2015[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 एंडोटैम्पोनैड्स नेत्र- सम्बंधी प्रत्यारोपण — (ISO 16672 : 2020, संिोजधत) ओकुलर एडं ोटैम्पोनैड्स 10 आई एस 18639 : 2024 6 िून 2024 आई एस/आई एस ओ 15798 : 6 जसतम्बर 2024 नेत्र प्रत्यारोपण — नेत्र जिस्ट्कोसर्िभकल 2013 उपकरण नेत्र-सम्बंधी प्रत्यारोपण — नेत्र- (ISO 15798 : 2022, संिोजधत) सम्बंधी जिस्ट्कोसर्िभकल उपकरण पी. रािेि, िैज्ञाजनक िी एिं उप महाजनिेिक (आई टी एस, पी आर टी एिं टी एन एम) [जिज्ञापन-III/4/असा./197/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 11th June 2024 Ref: HQ-PUB012/4/2020-PUB-BIS (899)—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) IS 7346 : 2024 IS 7346 - 1987 6 September 1 Thoracic Surgery Instruments — Rib 6 June 2024 Specification for Raspatories, 2024 Raspatories — Specification Rib, Semb’s Pattern (Second Revision) (First Revision) IS 7382 : 2024 6 September IS 7382 - 1987 Thoracic Surgery Instruments — Rib 2024 2 6 June 2024 Specification for Shears, Rib, Shears, Thomas Pattern — Price Thomas’ Pattern Specification (First Revision) (Second Revision) IS 10937 : 2024 6 September IS 10937 - 1984 3 Bull Nose Ring and Key — 6 June 2024 2024 Specification for Nose Ring Specification and Key, Bull (First Revision) 6 September IS 10938 : 2024 IS 10938 - 1984 2024 4 Double Edged Searcher with Handle 6 June 2024 Specification for Searcher, and Sheath — Specification Double Edged with Handle (First Revision) and Sheath 5 IS 10955 : 2024 6 June 2024 IS 10955 - 1984 6 September Veterinary Surgical Instruments — Specification for Gimlet for 20244 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] Gimlet for Trephine — Specification Trephine (First Revision) IS 11566 : 2024 6 September IS 11566 - 1986 6 Thoracic Surgery Instruments — 6 June 2024 2024 Specification for Valve Valve Retractors — Specification Retractors (First Revision) IS 12329 : 2024 6 September Veterinary Surgical Instruments — 2024 Self-Centring Bone Holding Forceps IS 12329 - 1988 7 6 June 2024 — Specification Specification for Self-Centring (First Revision) Bone Holding Forceps IS 12344 : 2024 6 September IS 12344 - 1988 8 Veterinary Surgical Instruments — 6 J u ne 2024 2024 Specification for Reduction Reduction Forceps — Specification Forceps (First Revision) IS 18614 : 2024 IS/ISO 16672 : 2015 6 September 9 Ophthalmic Implants — Ocular 6 June 2024 Ophthalmic Implants — 2024 Endotamponades Ocular (ISO 16672 : 2020, MOD) Endotamponades IS 18639 : 2024 IS/ISO 15798 : 2013 6 September 10 Ophthalmic Implants — Ophthalmic 6 June 2024 Ophthalmic Implants — 2024 Viscosurgical Devices Ophthalmic Viscosurgical (ISO 15798 : 2022, MOD) Devices P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./197/2024-25] 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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