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Date: 30-May-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

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The gazette notification issued by the Bureau of Indian Standards (BIS) announces the establishment of a new Indian Standard, IS 18079:2023/ISO 9269:1988, related to metal bone plates for surgical implants. It also specifies the withdrawal of existing standards, IS 11567 (Part 3): 1986 and IS 11567 (Part 4): 1986, which relate to specifications for holes and slots in metal bone plates.

Key Changes

  • IS 18079:2023/ISO 9269:1988, concerning 'Implants for Surgery — Metal Bone Plates — Holes and Slots in Metal Bone Plates Corresponding to Screws with Conical Under-Surface', has been established with effect from May 18, 2023.
  • IS 11567 (Part 3): 1986, 'Specification for Holes and Slots in Metal Bone Plates Part 3 Corresponding to Screws with Asymmetrical Thread and Conical Under-Surfaces', will be withdrawn on June 18, 2023.
  • IS 11567 (Part 4): 1986, 'Specification for Holes and Slots in Metal Bone Plates Part 4 Corresponding to Screws with symmetrical Thread and Conical Under-Surfaces', will be withdrawn on June 18, 2023.

Impact Analysis

Manufacturers of Metal Bone Plates

  • Action Item: Review current manufacturing processes and update them to comply with IS 18079:2023/ISO 9269:1988. Obtain necessary certifications.

Healthcare Providers and Surgeons

  • Action Item: Update inventory and procurement processes to ensure compliance with the new standard. Educate medical staff about the changes.

Bureau of Indian Standards (BIS)

  • Action Item: Develop and implement a monitoring and enforcement plan for the new standard.

Consumers/Patients

  • Action Item: No direct action required, but awareness of updated standards can empower patients to ask informed questions about their implants.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. IS 18079:2023/ISO 9269:1988: New Indian Standard concerning 'Implants for Surgery — Metal Bone Plates — Holes and Slots in Metal Bone Plates Corresponding to Screws with Conical Under-Surface'. IS 11567 (Part 3): 1986: Indian Standard 'Specification for Holes and Slots in Metal Bone Plates Part 3 Corresponding to Screws with Asymmetrical Thread and Conical Under-Surfaces' to be withdrawn. IS 11567 (Part 4): 1986: Indian Standard 'Specification for Holes and Slots in Metal Bone Plates Part 4 Corresponding to Screws with symmetrical Thread and Conical Under-Surfaces' to be withdrawn. Bureau of Indian Standards Rules, 2018: The rules under which the BIS operates and issues notifications.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-30052023-246177 xxxGIDHxxx CG-DL-E-30052023-246177 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 359] नई दिल्ली, मगं लिार, मई 30, 2023/ज्य ष्े ठ 9, 1945 No. 359] NEW DELHI, TUESDAY, MAY 30, 2023/JYAISHTHA 9, 1945 भारतीय मानक ब्य ूरो (उपभोक्त ा मामल ेजि भाग) अजधसचू ना नई दिल्ली, 19 मई, 2023 सिं भ:भ HQ-PUB012/4/2020-PUB-BIS (598).—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 जििरण इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गय ेहैं, तीसरे स्ट्तंभ में इंजगत जतजि को स्ट्िाजपत हो गय ेहैं| चौिे स्ट्तंभ में दिये गय ेमानकों के जििरण, यदि कोई हो तो ि ेभी साि-साि लाग ूरहेंग ेिब तक ि ेपााँचिें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने हैं। अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस जलए िापस होन ेंकी स.ं जतजि तिा िीर्भक िान ेह,ैं की सख्ं या, िर् भतिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 18079 : 2023/आई एस ओ 18 मई 2023 आई एस 11567 (भाग 3) : 1986 18 िून 2023 9269 : 1988 मेटल बोन प्लेट्स में छेि और स्ट्लॉट के जलए जिजिष्टता सिभरी के जलए प्रत्यारोपण — धातु से बनी हड्डी की प्लेटें — िंक्वाकार सतह स्ट्क्रू के भाग 3 असमजमत धागे और िंक्वाकार अनुरूप छेि अंडर-सतहों के साि पेंच के अनुरूप 3426 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] आई एस 11567 (भाग 4) : 1986 मेटल बोन प्लेट्स में छेि और स्ट्लॉट के जलए जिजिष्टता भाग 3 समजमत धागे और िंक्वाकार अंडर-सतहों के साि पेंच के अनुरूप पी. रािेि, िैज्ञाजनक एफ एिं उपमहाजनििे क (आई टी एस, पी आर टी , टी एन एम) [जिज्ञापन-III/4/असा./140/2023-24] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 19th May, 2023 Ref: HQ-PUB012/4/2020-PUB-BIS (598).—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 Establishment Standards to be withdrawn, if withdrawal any (1) (2) (3) (4) (5) 1 IS 18079 : 2023/ISO 9269 : 1988 18 May 2023 IS 11567 (Part 3) : 1986 18 June Implants for Surgery — Metal Bone Specification for Holes and Slots 2023 Plates — Holes and Slots in Metal Bone Plates Corresponding to Screws with Conical Part 3 Corresponding to Screws Under-Surface with Asymmetrical Thread and Conical Under-Surfaces IS 11567 (Part 4) : 1986 Specification for Holes and Slots in Metal Bone Plates Part 4 Corresponding to Screws with symmetrical Thread and Conical Under-Surfaces P. RAJESH, Scientist F & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./140/2023-24] 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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