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Date: 09-Sep-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 Description

  • This gazette notification from the Bureau of Indian Standards (BIS), dated September 9, 2024, announces the establishment of revised Indian Standards (IS) for various assistive devices and the withdrawal of older versions of these standards.
  • The notification is issued under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018.

Key Changes

  • Nine Indian Standards (IS) are affected. These revisions cover specifications for adjustable axillary crutches, folding wheelchairs (adult and junior sizes), modular lower limb orthotic components, and battery-operated motorized tricycles.
  • Two standards (IS 18665:2024 and IS 18831:2024) are replacing ISO 10328:2016 and ISO 17966:2016 respectively, but no older standards are being withdrawn in these cases.
  • Older versions of the IS standards are being withdrawn on March 4, 2025, while the new revised versions are effective from September 4, 2024.
  • The specific IS numbers and their revision details are listed in the gazette's schedule. For example, IS 5143:2024 (Third Revision) replaces IS 5143-1988 (Second Revision).

Impact Analysis

Manufacturers

  • Action Item: Manufacturers should review the updated standards and implement necessary changes to their production and quality control systems.

Consumers

  • Action Item: Consumers should look for assistive devices that comply with the latest BIS standards (IS numbers mentioned in the gazette).

Regulators

  • Action Item: Regulatory bodies should develop and implement enforcement strategies to ensure widespread adoption of the new standards.

Importers

  • Action Item: Importers should verify that their supply chains comply with the updated standards and obtain necessary certifications.

Key Entities Referenced

Bureau of Indian Standards (BIS): The issuing authority of the gazette notification. Responsible for setting and enforcing Indian Standards. Bureau of Indian Standards Rules, 2018: The legal framework under which the notification is issued. Rule 15, sub-rule (1) specifically governs the establishment and withdrawal of standards. Various Indian Standards (IS): Specific IS numbers (e.g., IS 5143, IS 7454, IS 9471, etc.) are listed and affected by this notification. These standards pertain to specifications for various assistive devices. ISO 10328:2016 and ISO 17966:2016: International Standards that are referenced and replaced by new Indian Standards in this notification.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-09092024-257010 xxxGIDExxx CG-DL-E-09092024-257010 असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 698] नई दिल्ली, सोम ार, जसतम्ब र 9, 2024/भाद्र 18 1946 No. 698] NEW DELHI, MONDAY, SEPTEMBER 9, 2024/BHADRA 18, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेज भाग) अजधसचू ना नई दिल्ली, 5 जसतम्बर, 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS(1023).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एति्द्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के ज रण 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 ज रण, यदि कोई हो तो े भी साि-साि लाग ू रहगें े िब तक े पााँच ें स्ट्तंभ में इंजगत जतजि को ापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि ापस ापस होन ेकी स.ं जतजि र् भतिा िीर्कभ जलए िान ेह,ैं की सख्ं या, र् भ तिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 5143 : 2024 आई एस 5143 – 1988 04 जसतम्बर 2024 04 माचभ 2025 एडिस्ट्टेबल एजक्सलरी बैसाखी — एडिस्ट्टेबल एजक्सलरी बैसाखी ज जिजि के जलए ज जिजि (तीसरा पनु रीक्षण) (िसू रा पनु रीक्षण) 5757 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] 2 आई एस 7454 : 2024 आई एस 7454 : 1991 04 जसतम्बर 2024 04 माचभ 2025 ज कलांगों के जलए उपकरण — पुनस्ट्िाभपन उपस्ट्कर — पजहए व्हीलचेयर, फोलल्डंग, यस्ट्क साइज़ ाली कुर्सभयां, फोलल्डंग, व्यस्ट्क — ज जिजि साईि — ज जिजि (िसू रा पनु रीक्षण) (पहला पुनरीक्षण) 3 आई एस 8086 : 2024 आई एस 8086 : 1991 04 जसतम्बर 2024 04 माचभ 2025 ज कलांगों के जलए उपकरण — पुनस्ट्िाभपन उपस्ट्कर — पजहए व्हीलचेयर, फोलल्डंग, छोटा साईज़ ाली कुर्सभयां, फोलल्डंग, छोटा — ज जिजि साईज़ — ज जिजि (िसू रा पनु रीक्षण) (पहला पुनरीक्षण) 4 आई एस 9471 (भाग 3) : 2024 आई एस 9471 (भाग III) – 04 जसतम्बर 2024 04 माचभ 2025 मॉड्यूलर लोअर ललंब के ऑिोटटक 1980 घटक — ज जिजि मॉड्यूलर लोअर ललंब के भाग 3 रकाब प्लेटें ऑिोटटक घटक के जलए ज जिजि (पहला पुनरीक्षण) भाग III रकाब प्लेटें 5 आई एस 9471 (भाग 4) : 2024 आई एस 9471 (भाग IV) – 04 जसतम्बर 2024 04 माचभ 2025 मॉड्यूलर लोअर ललंब के ऑिोटटक 1980 घटक — ज जिजि मॉड्यूलर लोअर ललंब के भाग 4 िोड़ यूजनट, टखना ऑिोटटक घटक के जलए ज जिजि (पहला पनु रीक्षण) भाग IV िोड़ यूजनट, टखना 6 आई एस 9471 (भाग 6) : 2024 आई एस 9471 (भाग 6) : 04 जसतम्बर 2024 04 माचभ 2025 मॉड्यूलर लोअर ललंब के ऑिोटटक 2000 घटक — ज जिजि माडयूली अध:् अंग हड्डी घटक भाग 6 ऑिोटटक जहप िॉइंट (िॉइंट भाग 6 हड्डी श्रोजण िोड़ — यूजनट, जहप ड्रॉप लॉक) ज जिजि (पहला पुनरीक्षण) 7 आई एस 9471 (भाग 7) : 2024 आई एस 9471 (भाग 7) : 04 जसतम्बर 2024 04 माचभ 2025 मॉड्यूलर लोअर ललंब के ऑिोटटक 2000 घटक — ज जिजि माड्यूली अध: अगं हड्डी घटक भाग 7 ऑिोटटक िोड़ बासभ, टखने — ज जिजि और घुटन े (ऊपरी और जनचल)े भाग 7 हड्डी धड़, टखना (पहला पुनरीक्षण) घुटना (ऊपरी जनम्न)[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 8 आई एस 17154 : 2024 आई एस 17154 : 2019 04 जसतम्बर 2024 04 माचभ 2025 बैटरी संचाजलत मोटरचाजलत बैटरी संचाजलत मोटरचाजलत जतपजहया साईदकल — ज जिजि जतपजहया साइदकल — ज जिजि (पहला पुनरीक्षण) 9 आई एस 18665 : 2024 लाग ूनहीं लाग ूनहीं 04 जसतम्बर 2024 आई एस ओ 10328 : 2016 प्रोस्ट्िेटटक्स — कृजत्रम जनचल ेअंगों का संरचनात्मक परीक्षण — अपेक्षाएाँ और परीक्षण पद्धजतया ाँ 10 आई एस 18831 : 2024 लाग ूनहीं लाग ूनहीं 04 जसतम्बर 2024 आई एस ओ 17966 : 2016 व्ताजिगत स्ट् च्छता के जलए सहायक उत्पाि — अपेक्षाएाँ और परीक्षण पद्धजतयााँ जनिात एस. हक़, ैज्ञाजनक - िी ए ं उप महाजनिेिक (प्रयोगिालाएाँ) [ज ज्ञापन-III/4/असा./468/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 5th September, 2024 Ref: HQ-PUB013/1/2020-PUB-BIS(1023).—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 5143 : 2024 IS 5143 – 1988 1 Adjustable Axillary Crutches — 04 September 2024 Specification for Adjustable 04 March 2025 Specification Axillary Crutches (Third Revision) (Second Revision) 04 September 2024 IS 7454 : 2024 IS 7454 : 1991 Rehabilitation Equipment — Rehabilitation Equipment — 2 04 March 2025 Wheelchairs, Folding, Adult Size Wheelchairs, Folding, Adult — Specification Size — Specification (Second Revision) (First Revision) 04 September 2024 3 IS 8086 : 2024 IS 8086 : 1991 04 March 2025 Rehabilitation Equipment — Rehabilitation Equipment —4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] Wheelchairs, Folding, Junior Size Wheelchairs, Folding, Junior — Specification Size — Specification (Second Revision) (First Revision) IS 9471 (Part III) – 1980 04 September 2024 IS 9471 (Part 3) : 2024 Specification for Modular Modular Lower Limb Orthotic Lower Limb Orthotic 4 04 March 2025 Components — Specification Components Part 3 Stirrup Plates Part III Stirrup Plates (First Revision) IS 9471 (Part IV) – 1980 04 September 2024 IS 9471 (Part 4) : 2024 Specification for Modular Modular Lower Limb Orthotic Lower Limb Orthotic 5 04 March 2025 Components — Specification Components Part 4 Joint Unit, Ankle Part IV Joint Unit, Ankle (First Revision) 04 March 2025 04 September 2024 IS 9471 (Part 6) : 2000 IS 9471 (Part 6) : 2024 Modular Lower Limb Orthotic Modular Lower Limb Orthotic Components Components — Specification 6 Part 6 Orthotic Hip Joint (Joint Part 6 Orthotic Hip Joint (Joint Unit, Hip Drop Lock) — Unit, Hip Drop Lock) Specification (First Revision) IS 9471 (Part 7) : 2000 04 September 2024 IS 9471 (Part 7) : 2024 Modular Lower Limb Orthotic Modular Lower Limb Orthotic Components — Specification 7 Components — Specification Part 7 Orthotic Joint Bars, 04 March 2025 Part 7 Orthotic Joint Bars, Ankle Ankle and Knee (Upper and and Knee (Upper and Lower) Lower) (First Revision) 04 September 2024 IS 17154 : 2019 IS 17154 : 2024 Battery Operated Motorized 8 Battery Operated Motorized 04 March 2025 Tricycle — Specification Tricycle — Specification (First Revision) 04 September 2024 IS 18665 : 2024 ISO 10328 : 2016 9 NA NA Prosthetics — Structural Testing of Lower-Limb Prostheses — Requirements and Test Methods 04 September 2024 IS 18831 : 2024 ISO 17966 : 2016 10 NA NA Assistive Products for Personal Hygiene that Support Users — Requirements and Methods of Test NISHAT S. HAQUE, Scientist G & DDG (Labs.) [ADVT.-III/4/Exty./468/2024-25] 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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