Home India Bureau of Indian Standards In pursuance of Sub rule (1) of Rule (15) of the Bureau of I...
Date: 14-Nov-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

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • This gazette notification issued by the Bureau of Indian Standards (BIS) announces the establishment of new Indian Standards (IS) and the concurrent validity of older standards until their withdrawal.
  • The notification specifies the dates on which new standards become effective and the dates on which older standards will be withdrawn.

Key Changes

  • Eleven new Indian Standards (IS) have been established, all effective from October 29, 2024.
  • Ten of these new standards replace older versions of the same standards, which will remain in force concurrently until April 29, 2025.
  • One new standard, IS 10258 (Part 4) : 2024, related to sterile hypodermic syringes, does not replace an existing standard.
  • One new standard, IS 18927: 2024 related to Cardiovascular Implants, does not replace an existing standard.
  • The older standards that are being replaced are from the years 1970, 1971, 1984, 1987, 2006, and 2015.
  • The new standards cover a range of products including skin grafting blades, potassium chloride, copper salts for electroplating, orthopaedic chisels and osteotomes, silver cyanide, bone clamps, sterile hypodermic syringes, health informatics, and cardiovascular implants.

Impact Analysis

Manufacturers and Suppliers

  • They should review the specific changes in each standard to identify any impact on their existing products.

Healthcare Providers

  • Hospitals and clinics should update their procurement policies to reflect the new standards.

Consumers

  • Awareness of these standards can help consumers make informed choices.

Regulatory Bodies

  • BIS may need to conduct audits and inspections to ensure compliance.

Action Items

  • All stakeholders should stay informed about the specific changes in each standard and seek clarification from BIS if needed.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating, implementing, and monitoring Indian Standards. Indian Standards (IS): Technical standards developed and maintained by the Bureau of Indian Standards, outlining specifications for various products and processes. IS 3759:2024: Indian Standard for Skin Grafting Blade Specification (Second Revision), replacing IS 3759-1987 IS 4150:2024: Indian Standard for Potassium Chloride, Technical Specification (Third Revision), replacing IS 4150-1984 IS 4847:2024: Indian Standard for Copper Salts for Electroplating Specification (Third Revision), replacing IS 4847:2006 IS 5580:2024: Indian Standard for Stille Pattern Orthopaedic Chisels Specification (First Revision), replacing IS 5580-1970 IS 5583:2024: Indian Standard for Stille Pattern Orthopaedic Osteotomes Specification (First Revision), replacing IS 5583-1970 IS 6267:2024: Indian Standard for Silver Cyanide and Silver Potassium Cyanide for Electroplating Specification (First Revision), replacing IS 6267-1971 IS 6319:2024: Indian Standard for Bone Clamp — Lowman Type Specification (First Revision), replacing IS 6319-1971 IS 10258 (Part 4):2024: Indian Standard for Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature, based on ISO 7886-4:2018 IS 18865 (Part 5):2024: Indian Standard for Health Informatics — Patient Healthcard Data Part 5 Identification Data, based on ISO 21549-5:2023, replacing IS/ISO 21549-5:2015 IS 18878:2024: Indian Standard for Health Informatics — HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM), based on ISO 10781:2023, replacing IS/ISO 10781:2015 IS 18927:2024: Indian Standard for Cardiovascular Implants — Transcatheter Cardiac Occluders, based on ISO 22679:2021 Bureau of Indian Standards Rules, 2018: The rules under which the Bureau of Indian Standards operates, specifically Rule 15(1) is referenced in the notification.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-18112024-258700 xxxGIDHxxx CG-DL-E-18112024-258700 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 915] नई दिल्ली, बहृ स्ट्प जतिार, निम्ब र 14, 2024/कार्तकभ 23, 1946 No. 915] NEW DELHI, THURSDAY, NOVEMBER 14, 2024/KARTIKA 23, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 8 निम् बर, 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1078).–––भारतीय मानक ब्यरू ो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के जििरण 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 जििरण, यदि कोई हो तो ि े भी साि-साि लाग ू रहगें े िब तक ि े पााँचि ें स्ट्तंभ में इंजगत जतजि को िापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ जतजि तिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस 3759 : 2024 29 अक्टूबर 2024 आई एस : 3759 – 1987 29 अप्रलै 2025 जस्ट्कन ग्राफ्टंग ब्लेड ब्लेड, जस्ट्कन ग्राफ्टंग के जलए (िसू रा पनु रीक्षण) जिजिजि (पहला पुनरीक्षण) 7368 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ जतजि तिा िीर्कभ (1) (2) (3) (4) (5) 2 आई एस 4150 : 2024 29 अक्टूबर 2024 आई एस : 4150 – 1984 29 अप्रलै 2025 पोटेजियम क्लोराइड, तकनीकी पोटेजियम क्लोराइड, तकनीकी — जिजिजि के जलए जिजिजि (तीसरा पनु रीक्षण) (िसू रा पनु रीक्षण) 3 आई एस 4847 : 2024 29 अक्टूबर 2024 आई एस 4847 : 2006 29 अप्रलै 2025 इलेक्रोप्लेटटंग के जलए कॉपर जिद्युतलेपन के जलए कॉपरसाल्ट साल्ट — जिजिजि — जिजिजि (तीसरा पनु रीक्षण ) (िसू रा पनु रीक्षण) 4 आई एस 5580 : 2024 29 अक्टूबर 2024 आई एस : 5580 – 1970 29 अप्रलै 2025 जस्ट्टल पैटनभ ऑिोपेजडक छेनी — छेनी, जस्ट्टल पैटन,भ ऑिोपेजडक के जिजिजि जलए जिजिजि (पहला पुनरीक्षण) 5 आई एस 5583 : 2024 29 अक्टूबर 2024 आई एस : 5583 – 1970 29 अप्रलै 2025 जस्ट्टल पैटनभ के ऑिोपेजडक अजस्ट्िजिच्छेिक, जस्ट्टल पैटन,भ अजस्ट्िजिच्छेिक — जिजिजि ऑिोपेजडक के जलए जिजिजि (पहला पुनरीक्षण) 6 आई एस 6267 : 2024 29 अक्टूबर 2024 आई एस : 6267 – 1971 29 अप्रलै 2025 इलेक्रोप्लेटटंग के जलए जसल्िर इलेक्रोप्लेटटंग के जलए जसल्िर साइनाइड और जसल्िर पोटेजियम साइनाइड और जसल्िर पोटेजियम साइनाइड — जिजिजि साइनाइड के जलए जिजिजि (पहला पनु रीक्षण) 7 आई एस 6319 : 2024 29 अक्टूबर 2024 आई एस : 6319 – 1971 29 अप्रलै 2025 हड्डी क्लैम्प — लोमैन प्रकार — क्लैम्प, हड्डी, लोमैन प्रकार के जिजिजि जलए जिजिजि (पहला पुनरीक्षण) 8 आई एस 10258 (भाग 4) : 29 अक्टूबर 2024 लाग ूनहीं लाग ूनहीं 2024 आई एस ओ 7886-4 : 2018 एक बार प्रयोग में आन े िाल े रोगाण ु मुक्त हाइपोडर्मभक जसटरंि भाग 4 पुन: उपयोग रोकिाम सुजिधा के साि जसटरंि 9 आई एस 18865 (भाग 5) : 29 अक्टूबर 2024 आई एस/आई एस ओ 21549-5 29 अप्रलै 2025 2024 : 2015 आई एस ओ 21549-5 : 2023 स्ट्िास्ट््य सूचना जिज्ञान — रोगी स्ट्िास्ट््य सूचना जिज्ञान — रोगी स्ट्िास्ट््य काडभ डेटा स्ट्िास्ट््य काडभ डेटा भाग 5 पहचान डेटा भाग 5 पहचान डेटा[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 क्रम स्ट्िाजपत भारतीय मानकों की प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि िापस िापस होन ेकी स.ं सख्ं या, िर् भतिा िीर्कभ जलए िान ेह,ैं की सख्ं या, िर् भ जतजि तिा िीर्कभ (1) (2) (3) (4) (5) 10 आई एस 18878 : 2024 29 अक्टूबर 2024 आई एस/आई एस ओ 10781 : 29 अप्रलै 2025 आई एस ओ 10781 : 2023 2015 स्ट्िास्ट््य सूचना जिज्ञान — एच स्ट्िास्ट््य सूचना जिज्ञान — एच एल 7 इलेक्रॉजनक स्ट्िास्ट््य एल 7 इलेक्रॉजनक स्ट्िास्ट््य ररकाडभ-प्रणाली कायाभत्मक मॉडल, ररकाडभ-प्रणाली कायाभत्मक मॉडल, ररलीज़ 2.1 (ईएचआर एफएम) ररलीज़ 2 ( ईएचआर एफएम ) 11 लाग ूनहीं आई एस 18927 : 2024 29 अक्टूबर 2024 लाग ूनहीं ह्रियिाजहनी प्रत्यारोपण — परा- नालिलाका हृिय अिरोधक (ISO 22679 : 2021, संिोजधत) जचत्रा गुप्ता, िैज्ञाजनक िी एिं उप महाजनिेिक (हॉलमार्किंग) [जिज्ञापन-III/4/असा./684/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 8th November, 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1078).––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 3759 : 2024 29 October 2024 IS : 3759 – 1987 29 April 2025 Skin Grafting Blade Specification for Blades, Skin (Second Revision) Grafting (First Revision) 2 IS 4150 : 2024 29 October 2024 IS : 4150 – 1984 29 April 2025 Potassium Chloride, Technical — Specification for Potassium Specification Chloride, Technical (Third Revision) (Second Revision) 3 IS 4847 : 2024 29 October 2024 IS 4847 : 2006 29 April 2025 Copper Salts for Electroplating — Copper Salts for Electroplating Specification — Specification4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] 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) (Third Revision) (Second Revision) 4 IS 5580 : 2024 29 October 2024 IS : 5580 – 1970 29 April 2025 Stille Pattern Orthopaedic Specification for Chisels, Stille Chisels — Specification Pattern, Orthopaedic (First Revision) 5 IS 5583 : 2024 29 October 2024 IS : 5583 – 1970 29 April 2025 Stille Pattern Orthopaedic Specification for Osteotomes, Osteotomes — Specification Stille Pattern, Orthopaedic (First Revision) 6 IS 6267 : 2024 29 October 2024 IS : 6267 – 1971 29 April 2025 Silver Cyanide and Silver Specification for Silver Potassium Cyanide for Cyanide and Silver Potassium Electroplating — Specification Cyanide for Electroplating (First Revision) 7 IS 6319 : 2024 29 October 2024 IS : 6319 – 1971 29 April 2025 Bone Clamp — Lowman Type — Specification for Clamp, Bone, Specification Lowman Type (First Revision) 8 IS 10258 (Part 4) : 2024 29 October 2024 NA NA ISO 7886-4 : 2018 Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature 9 IS 18865 (Part 5) : 2024 29 October 2024 IS/ISO 21549-5 : 2015 29 April 2025 ISO 21549-5 : 2023 Health Informatics — Patient Health Informatics — Patient Healthcard Data Healthcard Data Part 5 Identification Data Part 5 Identification Data 10 IS 18878 : 2024 29 October 2024 IS/ISO 10781 : 2015 29 April 2025 ISO 10781 : 2023 Health Informatics — HL7 Health Informatics — HL7 Electronic Health Records- Electronic Health Record-System System Functional Model, Functional Model, Release 2.1 Release 2 ( EHR FM ) (EHR FM) 11 IS 18927 : 2024 29 October 2024 NA NA Cardiovascular Implants — Transcatheter Cardiac Occluders (ISO 22679 : 2021, MOD) CHITRA GUPTA, Scientist G & DDG (Hallmarking) [ADVT.-III/4/Exty./684/2024-25] 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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