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Date: 30-May-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 Amendments

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 amendments to existing Indian standards. Specifically, it concerns amendments to standards related to the sterilization of health care products.

Key Changes

  • Amendment No. 2 to IS/ISO 11137-1:2006, concerning 'Sterilization of Health Care Products — Radiation, Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices' has been established.
  • The date of establishment of this amendment is May 21, 2024.
  • The existing standard IS/ISO 11137-1:2006, without Amendment No. 2, will remain in force until June 20, 2024.

Impact Analysis

Manufacturers of Medical Devices

  • Action Items: Review and update sterilization protocols to align with the new amendment. Ensure validation and routine control processes meet the updated requirements. Update documentation and training programs accordingly.

Healthcare Facilities

  • Action Items: Verify that medical devices procured are sterilized according to the amended standard IS/ISO 11137-1:2006. Update internal quality control procedures to reflect the changes.

Bureau of Indian Standards (BIS)

  • Action Items: Conduct audits and inspections to verify that manufacturers are adhering to the amended standard. Update certification processes to include the new amendment.

Consumers

  • Action Items: No direct action required, but increased awareness of the standards and their importance is beneficial.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. IS/ISO 11137-1:2006: Indian Standard/International Organization for Standardization standard related to the sterilization of health care products using radiation. Bureau of Indian Standards Rules, 2018: The 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.-01062024-254497 xxxGIDHxxx CG-DL-E-01062024-254497 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 384] नई दिल्ली, बहृ स्ट्प जतिार, मई 30, 2024/ज्य ष्े ठ 9, 1946 No. 384] NEW DELHI, THURSDAY, MAY 30, 2024/JYAISHTHA 9, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल् ली, 28 मई, 2024 सिं भ:भ HQ-PUB015/1/2020-PUB-BIS (896).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ैइसमें संलग्न अनूसूची में दिये गय ेमानकों में संिोधन दकये गय ेह|ैं अनसु चू ी क्रम स्ट्थाजपत भारतीय मानकों की संख्या, िर्भ तथा िीर्भक संिोधनों की संख्या संिोधनों की जतजथ िब तक मानक सं. एिं जतजथ प्रजतस्ट्थापन जतजथ तीसरे स्ट्तंभ में इंजगत संिोधन के जबना भी लागू रहगे ा (1) (2) (3) (4) (5) 1 आई एस/आई एस ओ 11137-1 : 2006 संिोधन संख्या 2 21 मई 2024 20 िून 2024 स्ट्िास्ट््य िेखभाल उत्पािों का जिसंक्रमण — जिदकरण मई 2024 भाग 1 जचदकत्सा उपकरणों के जलए एक जिसंक्रमण प्रदक्रया के जिकास, सत्यापन और दिनचयाभ पर जनयंत्रण के जलए आिश्यकताएँ पी. रािेि, िैज्ञाजनक िी एिं उप महाजनिेिक (आई टी एस, पी आर टी एि ं टी एन एम) [जिज्ञापन-III/4/असा./153/2024-25] 3299 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 28th May, 2024 Ref: HQ-PUB015/1/2020-PUB-BIS (896).—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 Amendments to Indian standards, particulars of which are given in schedule hereto annexed have been established. SCHEDULE Sl. No., Year & Title of the Indian Standard No. and Date of Date till which No. Month/Year of the Establishment the standard Amendment of the without the Amendment amendment as mentioned in column 3 shall remain in force (1) (2) (3) (4) (5) 1 IS/ISO 11137-1 : 2006 Amendment No. 2 21 May 2024 20 June 2024 Sterilization of Health Care Products — May 2024 Radiation Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./153/2024-25] 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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