Home India Bureau of Indian Standards In pursuance of Subrule 1 of Rule 15 of the Bureau of Indian...
Date: 20-Apr-2023 Category: Extra Ordinary State: Union Government Country: India

In pursuance of Subrule 1 of Rule 15 of the Bureau of Indian Standards Rules,

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 existing standards. This is done in accordance with Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018.
  • The new standards listed in the schedule will be in force from April 13, 2023. The older standards, which are being replaced, will be withdrawn on May 13, 2023.

Key Changes

  • IS 13450 (Part 2/Sec 19):2023/IEC 60601-2-19:2020 replaces IS 13450 (Part 2/Sec 19):2018/IEC 60601-2-19:2009 concerning Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 19: Infant Incubators. The new standard was established on April 13, 2023, and the old standard will be withdrawn on May 13, 2023.
  • IS 13450 (Part 2/Sec 20):2023 replaces IS 13450 (Part 2/Sec 20):2018/ IEC 60601-2-20:2009 concerning Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 20: Infant Transport Incubators. The new standard was established on April 13, 2023 and the old standard will be withdrawn on May 13, 2023.
  • IS 13450 (Part 2/Sec 21):2023/IEC 60601-2-21:2020 replaces IS 13450 (Part 2/Sec 21):2018/IEC 60601-2-21:2009 concerning Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 21: Infant Radiant Warmers. The new standard was established on April 13, 2023, and the old standard will be withdrawn on May 13, 2023.
  • IS 13450 (Part 2/Sec 35):2023/IEC 60601-2-35:2020 replaces IS/IEC 80601-2-35:2009 concerning Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 35: Heating Devices Using Blankets, Pads or Mattresses and Intended for Heating in Medical Use. The new standard was established on April 13, 2023, and the old standard will be withdrawn on May 13, 2023.
  • IS 18078:2023/ISO 5836:1988 replaces IS 11567 (Part 1):1986 concerning Implants for Surgery — Metal Bone Plates — Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-Surface Screws. The new standard was established on April 13, 2023, and the old standard will be withdrawn on May 13, 2023.

Impact Analysis

Manufacturers of Medical Electrical Equipment

  • Manufacturers should obtain necessary certifications for the updated products to demonstrate compliance.

Manufacturers of Surgical Implants

  • Manufacturers should obtain necessary certifications for the updated products to demonstrate compliance.

Hospitals and Healthcare Providers

  • Ensure biomedical engineering staff are trained on the new standards and equipment specifications.

Bureau of Indian Standards (BIS)

  • Update certification processes to reflect the new standards and ensure that certified products meet the latest requirements.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for the formulation, recognition and promotion of standards for goods and services. IS 13450 (Part 2/Sec 19):2023/IEC 60601-2-19:2020: Indian Standard for Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 19: Infant Incubators. IS 13450 (Part 2/Sec 20):2023: Indian Standard for Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 20: Infant Transport Incubators. IS 13450 (Part 2/Sec 21):2023/IEC 60601-2-21:2020: Indian Standard for Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 21: Infant Radiant Warmers. IS 13450 (Part 2/Sec 35):2023/IEC 60601-2-35:2020: Indian Standard for Medical Electrical Equipment, Part 2: Particular Requirements for Basic Safety and Essential Performance, Section 35: Heating Devices Using Blankets, Pads or Mattresses and Intended for Heating in Medical Use. IS 18078:2023/ISO 5836:1988: Indian Standard for Implants for Surgery — Metal Bone Plates — Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-Surface Screws. 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.-21042023-245292 xxxGIDHxxx CG-DL-E-21042023-245292 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 253] नई दिल्ली, बृहस्ट्प जतिार, अप्रलै 20, 2023/चत्रै 30, 1945 No. 253] NEW DELHI, THURSDAY, APRIL 20, 2023/CHAITRA 30, 1945 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 17 अप्रैल, 2023 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (565) .—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनसु रण में भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता है की जिन भारतीय मानकों के जििरण इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गय ेह,ैं तीसरे स्ट्तंभ में इंजगत जतजि को स्ट्िाजपत हो गय ेह|ैं चौिे स्ट्तंभ में दिये गये मानकों के जििरण, यदि कोई हो तो ि ेभी साि-साि लाग ूरहेंग ेिब तक ि ेपााँचिें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने ह ैं| अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी स.ं तिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ जतजि तिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 13450 (भाग 2/अनुभाग 19) : 13 अप्रैल 2023 आई एस 13450 (भाग 13 मई 2023 2023/आई ई सी 60601-2-19 : 2020 2/अनुभाग 19) : 2018/आई ई जचदकत्सीय जिद्युत् उपस्ट्कर सी 60601-2-19 : 2009 भाग 2 बुजनयािी सुरक्षा और आिश्यक कायभ जचदकत्सीय जिद्युत उपस्ट्कर जनष्पािन के जलए जििेर् आिश्यकताएाँ भाग 2 बुजनयािी सुरक्षा एिं अनुभाग 19 जििु इनक्यूबेटर आिश्यक जनष्पािन के जलये 2573 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् भ प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी स.ं तिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ जतजि तिा िीर्कभ (1) (2) (3) (4) (5) (पहला पुनरीक्षण) जिजिष्ट अपेक्षाएाँ अनुभाग 19 बेबी इनक्यूबेटर 2 आई एस 13450 (भाग 2/अनुभाग 20) : 13 अप्रैल 2023 आई एस 13450 (भाग 13 मई 2023 2023 2/अनुभाग 20) : 2018/आई ई जचदकत्सीय जिद्युत् उपस्ट्कर सी 60601-2-20 : 2009 भाग 2 बुजनयािी सुरक्षा और आिश्यक कायभ जचदकत्सीय जिद्युत उपस्ट्कर जनष्पािन के जलए जििेर् आिश्यकताएाँ भाग 2 बुजनयािी सुरक्षा और अनुभाग 20 जििु पररिहन इनक्यूबेटर आिश्यक कायभ जनष्पािन के जलए (IEC 60601-2-20 : 2020, संिोजधत) जििेर् आिश्यकताएं (पहला पुनरीक्षण) अनुभाग 20 जििु पररिहन इंक्यूबेटसभ 3 आई एस 13450 (भाग 2/अनुभाग 21) : 13 अप्रैल 2023 आई एस 13450 (भाग 13 मई 2023 2023/आई ई सी 60601-2-21 : 2020 2/अनुभाग 21) : 2018/आई ई जचदकत्सीय जिद्युत् उपस्ट्कर सी 60601-2-21 : 2009 भाग 2 बुजनयािी सुरक्षा और आिश्यक कायभ जचदकत्सीय जिद्युत उपस्ट्कर जनष्पािन के जलए जििेर् आिश्यकताएाँ भाग 2 बुजनयािी सुरक्षा और अनुभाग 21 जििु रेजडयंट िामभर आिश्यक कायभ जनष्पािन के जलए (पहला पुनरीक्षण) जििेर् आिश्यकताएं अनुभाग 21 जििु रेजडयंट िामभर 4 आई एस 13450 (भाग 2/अनुभाग 35) : 13 अप्रैल 2023 आई एस/आई ई सी 80601-2- 13 मई 2023 2023/आई ई सी 60601-2-35 : 2020 35 : 2009 जचदकत्सीय जिद्युत् उपस्ट्कर जचदकत्सीय जिद्युत उपस्ट्कर भाग 2 बुजनयािी सुरक्षा और आिश्यक कायभ भाग 2 बुजनयािी सुरक्षा और जनष्पािन के जलए जििेर् आिश्यकताएाँ आिश्यक कायभ जनष्पािन के जलए अनुभाग 35 कंबल, पैड या गद्दे का उपयोग जििेर् आिश्यकताऐ करने िाले एिं जचदकत्सीय उपयोग हते ु अनुभाग 35 हीटटंग जडिाइस के हीटटंग उपकरण रूप में कंबल, पैड या गद्दे और जचदकत्सा उपयोग में हीटटंग के जलए अजभप्रेत 5 आई एस 18078 : 2023/आई एस ओ 13 अप्रैल 2023 आई एस 11567 (भाग 1) : 13 मई 2023 5836 : 1988 1986 सिभरी के जलए प्रत्यारोपण — धातु से बनी मेटल बोन प्लेट्स के जलए छेि हड्डी की प्लेटें — असमजमत थ्रेड और गोल और स्ट्लॉट के जलए जिजिष्टता सतह स्ट्क्रू के अनुरूप छेि भाग 1 असमजमत धागे और गोलाकार अंडर-सतहों के साि पेंच के अनुरूप पी. रािेि, िैज्ञाजनक एफ एि ंउपमहाजनिेिक (आई टी एस, पी आर टी, टी एन एम) [जिज्ञापन-III/4/असा./33/2023-24][भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 17th April, 2023 Ref: HQ-PUB013/1/2020-PUB-BIS (565).—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) 1 IS 13450 (Part 2/Sec 19) : 2023/IEC 13 April 2023 IS 13450 (Part 2/Sec 19) : 13 May 60601-2-19 : 2020 2018/IEC 60601-2-19 : 2009 2023 Medical Electrical Equipment Medical Electrical Equipment Part 2 Particular Requirements for Basic Part 2 Particular Requirements Safety and Essential Performance for the Basic Safety and Section 19 Infant Incubators Essential Performance (First Revision) Section 19 Baby Incubators 2 IS 13450 (Part 2/Sec 20) : 2023 13 April 2023 IS 13450 (Part 2/Sec 20) : 13 May Medical Electrical Equipment 2018/ IEC 60601-2-20 : 2009 2023 Part 2 Particular Requirements for Basic Medical Electrical Equipment Safety and Essential Performance Part 2 Particular Requirements Section 20 Infant Transport Incubators for the Basic Safety and (IEC 60601-2-20 : 2020, MOD) Essential Performance (First Revision) Section 20 Infant Transport Incubators 3 IS 13450 (Part 2/Sec 21) : 2023/IEC 13 April 2023 IS 13450 (Part 2/Sec 21) : 13 May 60601-2-21 : 2020 2018/IEC 60601-2-21 : 2009 2023 Medical Electrical Equipment Medical Electrical Equipment Part 2 Particular Requirements for Basic Part 2 Particular Requirements Safety and Essential Performance for the Basic Safety and Section 21 Infant Radiant Warmers Essential Performance (First Revision) Section 21 Infant Radiant Warmers 4 IS 13450 (Part 2/Sec 35) : 2023/IEC 13 April 2023 IS/IEC 80601-2-35 : 2009 13 May 60601-2-35 : 2020 Medical Electrical Equipment 2023 Medical Electrical Equipment Part 2 Particular Requirements Part 2 Particular Requirements for Basic for Basic Safety and Essential Safety and Essential Performance Performance Section 35 Heating Devices Using Section 35 Heating Devices Blankets, Pads or Mattresses and Using Blankets, Pads or Intended for Heating in Medical Use Mattresses and Intended for Heating in Medical Use 5 IS 18078 : 2023/ISO 5836 : 1988 13 April 2023 IS 11567 (Part 1) : 1986 13 May Implants for Surgery — Metal Bone Specification for Holes and 2023 Plates — Holes Corresponding to Screws Slots for Metal Bone Plates with Asymmetrical Thread and Spherical Part 1 Corresponding to Under-Surface Screws with Asymmetrical Thread and Spherical Under- Surfaces P. RAJESH, Scientist F & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./33/2023-24] 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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