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Date: 10-Feb-2025 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

  • The gazette notification issued by the Bureau of Indian Standards (BIS) announces the establishment of new Indian Standards and the withdrawal of certain existing standards. This is in accordance with Rule 15(1) of the Bureau of Indian Standards Rules, 2018.
  • The notification specifies the date on which the new standards are established and, where applicable, the date on which the superseded standards will be withdrawn.

Key Changes

  • IS 6053 (Part 5): 2025, concerning hand tools for the footwear industry, has been established on January 29, 2025, and replaces IS 6053 (Part V) – 1972. The older standard will be withdrawn on July 29, 2025.
  • IS 18917: 2025, related to ophthalmic optics and mounted spectacle lenses based on ISO 21987: 2017, has been established on January 29, 2025.
  • IS 18950: 2025, concerning the wear of implant materials based on ISO 17853: 2011, has been established on January 29, 2025.
  • IS 18984: 2025, addressing implants for surgery and the assessment of absorbable metallic implants based on ISO/TS 20721: 2020, has been established on January 29, 2025.
  • IS 18985: 2025, specifying synthetic anatomical bone models for testing surgical implants based on ISO 22926: 2023, has been established on January 29, 2025.
  • IS 18986: 2025, concerning Roentgen stereo photogrammetric analysis for assessing the migration of orthopaedic implants based on ISO 16087: 2013, has been established on January 29, 2025.

Impact Analysis

Footwear Industry

  • Action Items: Footwear manufacturers should review and update their hand tool specifications and procurement processes. Suppliers should ensure their products meet the new standards. Quality control agencies need to update their testing protocols.

Ophthalmic Industry

  • Action Items: Manufacturers should align their production processes with IS 18917: 2025. Opticians should be aware of the new standards when sourcing lenses.

Medical Device Industry (Implants)

  • Action Items: Manufacturers must update their manufacturing and testing protocols to comply with the new Indian Standards. Hospitals and surgeons should be aware of these standards to ensure the use of compliant and safe implants. Regulatory bodies need to enforce these standards through audits and certifications.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. IS 6053 (Part 5): 2025: Indian Standard for Hand Tools for Footwear Industry — Specification Part 5 Straight Hacking Knife (First Revision). IS 6053 (Part V) – 1972: Previous Indian Standard for Hand Tools for Footwear Industry — Specification Part V Straight Hacking Knife, now being withdrawn. IS 18917: 2025: Indian Standard for Ophthalmic Optics — Mounted Spectacle Lenses, based on ISO 21987: 2017. ISO 21987: 2017: International Standard for Ophthalmic Optics — Mounted Spectacle Lenses. IS 18950: 2025: Indian Standard for Wear of Implant Materials — Polymer and Metal Wear Particles — Isolation and Characterization, based on ISO 17853: 2011. ISO 17853: 2011: International Standard for Wear of Implant Materials — Polymer and Metal Wear Particles — Isolation and Characterization. IS 18984: 2025: Indian Standard for Implants for Surgery — General Guidelines and Requirements for Assessment of Absorbable Metallic Implants, based on ISO/TS 20721: 2020. ISO/TS 20721: 2020: International Standard for Implants for Surgery — General Guidelines and Requirements for Assessment of Absorbable Metallic Implants. IS 18985: 2025: Indian Standard for Implants for Surgery — Specification and Verification of Synthetic Anatomical Bone Models for Testing, based on ISO 22926: 2023. ISO 22926: 2023: International Standard for Implants for Surgery — Specification and Verification of Synthetic Anatomical Bone Models for Testing. IS 18986: 2025: Indian Standard for Implants for Surgery — Roentgen Stereo Photogrammetric Analysis for the Assessment of Migration of Orthopaedic Implants, based on ISO 16087: 2013. ISO 16087: 2013: International Standard for Implants for Surgery — Roentgen Stereo Photogrammetric Analysis for the Assessment of Migration of Orthopaedic Implants. Bureau of Indian Standards Rules, 2018: The rules under which the Bureau of Indian Standards operates and establishes standards.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-11022025-260887 xxxGIDHxxx CG-DL-E-11022025-260887 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 99] नई दिल्ली, सोमिार, फरिरी 10, 2025/माघ 21, 1946 No. 99] NEW DELHI, MONDAY, FEBRUARY 10, 2025/MAGHA 21, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल े जिभाग) अजधसचू ना नई दिल्ली, 30 िनिरी, 2025 सिं भ भ :HQ-PUB013/ 1/ 2020-PUB-BIS (1155)— 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 इसम ें संलग्न अनूसूची के जद्वतीय स्ट्तंभ म ें दिय े गय े ह,ैं तीसरे स्ट्तभं म ें इंजगत जतजि को स्ट्िाजपत हो गय े ह|ैं चौिे स्ट्तंभ म ें दिय े गय े मानकों के जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचि ें स्ट्तंभ म ें इंजगत जतजि को िापस जलए िाने ह|ैं अनसु चू ी क्रम स्थापित भारतीय मानकों की संख्या, वर्ष प्रपतस्थािन पतपथ भारतीय मानकों, यपि वािस पिए जाने हैं, वािस होने की सं. तथा शीर्षक की संख्या, वर्ष तथा शीर्षक पतपथ (1) (2) (3) (4) (5) 1 29 जनिरी 2025 29 जुिाई 2025 आई एस 6053 (भाग 5) : 2025 आई एस 6053 (भाग V) – 1972 फुटवियर उद्योग के विए हाथ के उपकरण — फुटवियर उद्योग के विए हाथ के उपकरण के विविवि विए विविवि भाग 5 सीधा हवैकिंग चाकू भाग V सीधा हैवकिंग चाकू (पहिा पुनरीक्षण) 996 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्थापित भारतीय मानकों की संख्या, वर्ष प्रपतस्थािन पतपथ भारतीय मानकों, यपि वािस पिए जाने हैं, वािस होने की सं. तथा शीर्षक की संख्या, वर्ष तथा शीर्षक पतपथ (1) (2) (3) (4) (5) 2 29 जनिरी 2025 आई एस 18917 : 2025 िागू नही िागू नही आई एस ओ 21987 : 2017 नेत्र सिंबिंधी प्रकाविकी — माउिंटेड चश्मे के िेंस 3 29 जनिरी 2025 आई एस 18950 : 2025 िागू नही िागू नही आई एस ओ 17853 : 2011 प्रत्यारोपण सामग्री का विसाि — पॉविमर और धातु के विसाि के कण — अिगाि और िक्षण िणणन 4 29 जनिरी 2025 आई एस 18984 : 2025 िागू नही िागू नही आई एस ओ/टी एस 20721 : 2020 सजणरी के विए प्रत्यारोपण — अििोवित करने योग्य धातु प्रत्यारोपण के मलू यािंकन के विए सामान्य वििावनिेि और अपेक्षाएँ 5 29 जनिरी 2025 आई एस 18985 : 2025 िागू नही िागू नही आई एस ओ 22926 : 2023 सजणरी के विए प्रत्यारोपण — परीक्षण के विए कृवत्रम सिंरचनात्मक हड्डी मॉडि की विविवि और सत्यापन 6 29 जनिरी 2025 आई एस 18986 : 2025 िागू नही िागू नही आई एस ओ 16087 : 2013 सजणरी के विए प्रत्यारोपण — आथोपेवडक प्रत्यारोपण के प्रिासन के आिंकिन के विए रोएिंटजेन स्टीररयो फोटोग्रामेविक विश्लेिण जचत्रा गुप्ता िैज्ञाजनक िी एि ं उप महाजनिेिक (हॉलमार्किंग एि ं रेननंग) [जिज्ञापन-III/4/असा./956/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 30th January, 2025 Ref :HQ-PUB013/1/ 2020-PUB-BIS (1155).—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 Standards Date of No. , Year & Title of the Date of Withdrawal No. Established Establishment Indian Standards to be Withdrawn, if any (1) (2) (3) (4) (5)[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 Sl No., Year & Title of the Indian Standards Date of No. , Year & Title of the Date of Withdrawal No. Established Establishment Indian Standards to be Withdrawn, if any (1) (2) (3) (4) (5) 29 January 2025 29 July 2025 1 IS 6053 (Part 5) : 2025 IS 6053 (Part V) – 1972 Hand Tools for Footwear Industry — Specification for Hand Tools for Specification Footwear Industry Part 5 Straight Hacking Knife Part V Straight Hacking Knife (First Revision) 29 January 2025 NA 2 IS 18917 : 2025 NA ISO 21987 : 2017 Ophthalmic Optics — Mounted Spectacle Lenses 29 January 2025 NA 3 IS 18950 : 2025 NA ISO 17853 : 2011 Wear of Implant Materials — Polymer and Metal Wear Particles — Isolation and Characterization 29 January 2025 NA 4 IS 18984 : 2025 NA ISO/TS 20721 : 2020 Implants for Surgery — General Guidelines and Requirements for Assessment of Absorbable Metallic Implants 29 January 2025 NA 5 IS 18985 : 2025 NA ISO 22926 : 2023 Implants for Surgery — Specification and Verification of Synthetic Anatomical Bone Models for Testing 29 January 2025 NA 6 IS 18986 : 2025 NA ISO 16087 : 2013 Implants for Surgery — Roentgen Stereo Photogrammetric Analysis for the Assessment of Migration of Orthopaedic Implants CHITRA GUPTA, Scientist G & DDG (Hallmarking and Training) [ADVT.-III/4/Exty./956/2024-25] 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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