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Date: 19-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,

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Bureau of Indian Standards (BIS) has notified the establishment of a new Indian Standard and the withdrawal of an existing one related to medical electrical equipment, specifically critical care ventilators.

Key Changes

  • IS 13450 (Part 2/Sec 12) : 2023/ISO 80601-2-12 : 2020 Medical Electrical Equipment Part 2-12 Particular Requirements for Basic Safety and Essential Performance Section 12 Critical Care Ventilators has been established on May 18, 2023.
  • IS/ISO 80601-2-12 : 2011 Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Critical Care Ventilators will be withdrawn on June 18, 2023.

Impact Analysis

Manufacturers of Critical Care Ventilators

  • Action Item: Review and update manufacturing processes and product designs to align with the new standard.

Hospitals and Healthcare Providers

  • Action Item: Update procurement policies to reflect the new standard. Assess the impact on existing inventory and plan for upgrades or replacements as necessary.

Bureau of Indian Standards (BIS)

  • Action Item: Develop and implement a communication plan to inform stakeholders about the changes. Prepare for compliance monitoring activities.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. IS 13450 (Part 2/Sec 12) : 2023/ISO 80601-2-12 : 2020: The new Indian Standard for Medical Electrical Equipment Part 2-12 Particular Requirements for Basic Safety and Essential Performance Section 12 Critical Care Ventilators. IS/ISO 80601-2-12 : 2011: The older Indian Standard for Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Critical Care Ventilators, which is being withdrawn. Indian Standards Act, 2018: Governs the operations 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.-19052023-245961 xxxGIDHxxx CG-DL-E-19052023-245961 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 332] नई दिल्ली, िुक्रिार, मई 19, 2023/ििै ाख 29, 1945 No. 332] NEW DELHI, FRIDAY, MAY 19, 2023/VAISAKHA 29, 1945 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 18 मई, 2023 स.ंHQ-PUB013/1/2020-PUB-BIS(593).—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 ें दिये गय े हैं, तीसरे स्ट्तंभ 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 िे पााँचिें स्ट्तंभ में इंजगत जतजि को िापस जलए िान े ह ैं | अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, िर् ष प्रजतस्ट्िापन भारतीय मानकों, यदि िापस जलए िापस होने सं. जतजि की जतजि तिा िीर्षक िाने ह,ैं की संख्या, िर् ष तिा िीर्षक (1) (2) (3) (4) (5) 1 आई एस 13450 (भाग 2/अनभु ाग 12) 18 मई 2023 आई एस/आई एस ओ 80601-2- 18 िून : 2023/आई एस ओ 80601-2-12 : 12 : 2011 2023 3211 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] 2020 जचदकत्सीय जिद्युत उपस्ट्कर जचदकत्सीय जिद्युत उपकरण भाग 2-12 दक्रटटकल केयर भाग 2 बुजनयािी सुरक्षा और आिश्यक िेंटटलेटर की बुजनयािी सुरक्षा और आिश्यक कायष जनष्पािन के जलए कायष जनष्पािन के जलए जििेर् अपेक्षाएाँ जििेर् आिश्यकताए ं अनुभाग 12 दक्रटटकल केयर िेंटटलेटर पी रािेि, िैज्ञाजनक एफ एिं उप महाजनिेिक (आई टी एस, पी आर टी , टी एन एम) [जिज्ञापन-III/4/असा./113/2023-24] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 18th May, 2023 Ref:HQ-PUB013/1/2020-PUB-BIS(593).—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. THE 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 12) : 2023/ISO 18 May 2023 IS/ISO 80601-2-12 : 2011 18 June 80601-2-12 : 2020 Medical Electrical Equipment 2023 Medical Electrical Equipment Part 2-12 Particular Part 2 Particular Requirements for Basic Requirements for Basic Safety Safety and Essential Performance and Essential Performance Section 12 Critical Care Ventilators Critical Care Ventilators P. RAJESH, Scientist F & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./113/2023-24] 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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