Home India Bureau of Indian Standards In pursuance of Sub rule 1 of Rule 15 of the Bureau of India...
Date: 29-Apr-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

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 two Indian Standards related to the sterilization of health care products.

Key Changes

  • Amendment No. 1 to IS/ISO 11137-2:2013 (Sterilization of Health Care Products - Radiation, Part 2: Establishing the Sterilization Dose) was established on April 22, 2024, and the standard without this amendment will remain in force until May 21, 2024.
  • Amendment No. 1 to IS/ISO 11737-1:2018 (Sterilization of Health Care Products - Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products) was established on April 22, 2024, and the standard without this amendment will remain in force until May 21, 2024.

Impact Analysis

Stakeholders

  • Consumers: Patients benefit from the assurance that health care products are properly sterilized.

Suggested Action Items

  • BIS should conduct awareness programs to educate manufacturers and healthcare providers about the amendments.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards. IS/ISO 11137-2:2013: Indian Standard/International Organization for Standardization standard for Sterilization of Health Care Products - Radiation, Part 2: Establishing the Sterilization Dose. IS/ISO 11737-1:2018: Indian Standard/International Organization for Standardization standard for Sterilization of Health Care Products - Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products. Bureau of Indian Standards Rules, 2018: The rules governing the functioning of the Bureau of Indian Standards.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-30042024-253968 xxxGIDHxxx CG-DL-E-30042024-253968 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 295] नई दिल्ली, सोमिार, अप्रैल 29, 2024/ििै ाख 9, 1946 No. 295] NEW DELHI, MONDAY, APRIL 29, 2024/VAISAKHA 9, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 24 अप्रलै , 2024 सिं भ:भ HQ-PUB015/1/2020-PUB-BIS (838).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एति्द्वारा अजधसूजचत करता ह ै इसम ें संलग्न अनूसूची म ें दिय े गय े मानकों में संिोधन दकये गय ेह ैं। अनसु चू ी क्रम स्ट्थाजपत भारतीय मानकों की सख्ं या, िर् भतथा सिं ोधनों की सख्ं या एि ं सिं ोधनों की जतजथ िब तक मानक स.ं जतजथ प्रजतस्ट्थापन जतजथ तीसरे स्ट्तंभ म ेंइंजगत िीर्कभ सिं ोधन के जबना भी लाग ूरहगे ा (1) (2) (3) (4) (5) 1 आई एस/आई एस ओ 11137-2 : 2013 संिोधन संख्या 1 22 अप्रैल 2024 21 मई 2024 स्ट्िास्ट््य िेखभाल उत्पािों का जिसंक्रमण — अप्रैल 2024 जिदकरण भाग 2 जिसंक्रमण की डोज़ स्ट्थाजपत करना 2804 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] 2 आई एस/आई एस ओ 11737-1 : 2018 संिोधन संख्या 1 22 अप्रैल 2024 21 मई 2024 स्ट्िास्ट््य िेखभाल उत्पािों का जनिभमभन — अप्रैल 2024 सूक्ष्मिैजिकीय जिजधयााँ भाग 1 उत्पािों पर सूक्ष्मिीिों की आबािी का जनधाभरण पी. रािेि, िैज्ञाजनक िी एिं उप महाजनिेिक (आई टी एस, पी आर टी एिं टी एन एम) [जिज्ञापन-III/4/असा./064/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 24th April, 2024 Ref: HQ-PUB015/1/2020-PUB-BIS(838).—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 No. and Date of Date till which No. Standard Month/Year of Establishment the standard the Amendment of the without the Amendment amendment as mentioned in column 3 shall remain in force (1) (2) (3) (4) (5) 1 IS/ISO 11137-2 : 2013 Amendment No. 1 22 April 2024 21 May 2024 Sterilization of Health Care Products — April 2024 Radiation Part 2 Establishing the Sterilization Dose 2 IS/ISO 11737-1 : 2018 Amendment No. 1 22 April 2024 21 May 2024 Sterilization of Health Care Products — April 2024 Microbiological Methods Part 1 Determination of a Population of Microorganisms on Products P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./064/2024-25] 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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