Date: 02-Jan-2024Category: Extra OrdinaryState: Union GovernmentCountry: 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 Indian standards, particulars of which are given in the second column
The gazette notification issued by the Bureau of Indian Standards (BIS) announces the establishment of four new Indian Standards. These standards pertain to in-vitro diagnostic (IVD) devices, electrical equipment for measurement, control, and laboratory use, and bullet-resistant security glass.
The notification is issued in pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018.
Key Changes
Four new Indian Standards have been established on December 28, 2023:
IS 17784 (Part 2) : 2023 - Electrical Equipment for Measurement, Control and Laboratory Use — EMC Requirements - Part 2 Particular Requirements for In-vitro Diagnostic (IVD) Medical Equipment (IEC 61326-2-6 : 2020, MOD)
IS 18518 : 2023 - Bullet Resistant Security Glass — Quality and Performance Requirements
The established standards do not replace any existing standards and no standards are being withdrawn through this notification.
Impact Analysis
Manufacturers of IVD Devices and related equipment
Action Items: Review existing manufacturing processes and product designs to ensure compliance with the requirements outlined in the new standards. Obtain necessary certifications from BIS to demonstrate compliance.
Manufacturers of Bullet Resistant Security Glass
Action Items: Evaluate current production methods and product specifications against IS 18518:2023. Implement necessary changes to meet the standard's requirements and obtain BIS certification.
Laboratories and Healthcare Facilities
Action Items: Prioritize procurement of IVD equipment that conforms to IS 17717 (Part 1), IS 17717 (Part 2) and IS 17784 (Part 2). Update internal quality control procedures to reflect the new standards.
Security Agencies and Building Developers
Action Items: Update procurement policies to specify the use of bullet-resistant security glass that is certified to IS 18518:2023. Verify compliance through testing and certification.
Bureau of Indian Standards (BIS)
Action Items: Conduct audits and inspections of manufacturers to verify compliance with the new standards. Provide guidance and support to manufacturers to facilitate adoption of the standards.
Key Entities Referenced
Bureau of Indian Standards (BIS): The national standards body of India responsible for the formulation, implementation, and promotion of standards.
IS 17717 (Part 1) : 2023: Indian Standard for In-Vitro Diagnostic (IVD) Device — Automated Clinical Chemistry Analyzer - Part 1 Wet Chemistry Analyzer
IS 17717 (Part 2) : 2023: Indian Standard for In-Vitro Diagnostic (IVD) Device — Automated Clinical Chemistry Analyzer - Part 2 Dry Chemistry Analyzer
IS 17784 (Part 2) : 2023: Indian Standard for Electrical Equipment for Measurement, Control and Laboratory Use — EMC Requirements - Part 2 Particular Requirements for In-vitro Diagnostic (IVD) Medical Equipment (IEC 61326-2-6 : 2020, MOD)
IS 18518 : 2023: Indian Standard for Bullet Resistant Security Glass — Quality and Performance Requirements
Bureau of Indian Standards Rules, 2018: The rules governing the operations and functions of the Bureau of Indian Standards.
IEC 61326-2-6 : 2020: International Electrotechnical Commission standard for Electrical Equipment for Measurement, Control and Laboratory Use — EMC Requirements - Part 2 Particular Requirements for In-vitro Diagnostic (IVD) Medical Equipment
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-03012024-251118
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CG-DL-E-03012024-251118
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असाधारण
EXTRAORDINARY
भाग III—खण् ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 09] नई ददल्ली, मगं ल ार, िन री 2, 2024/पौर् 12, 1945
No. 09] NEW DELHI, TUESDAY, JANUARY 2, 2024/PAUSHA 12, 1945
भारतीय मानक ब्य रू ो
(उपभोक्त ा मामल ेज भाग)
अजधसचू ना
नई ददल्ली, 1 िन री, 2024
सदं भ:भ HQ-PUB013/1/2020-PUB-BIS (763).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1)
के अनुसरण में भारतीय मानक ब्यूरो एतदद्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के ज रण इसमें संलग्न अनूसूची के
जद्वतीय स्ट्तंभ में ददये गये हैं, तीसरे स्ट्तंभ में इंजगत जतजथ को स्ट्थाजपत हो गये ह|ैं चौथे स्ट्तंभ में ददये गये मानकों के ज रण, यदद कोई हो
तो े भी साथ-साथ लागू रहेंगे िब तक े पााँच ें स्ट्तंभ में इंजगत जतजथ को ापस जलए िाने हैं ।
अनसु चू ी
क्रम स्ट्थाजपत भारतीय मानकों की संख्या, र्भ प्रजतस्ट्थापन जतजथ भारतीय मानकों, यदद ापस जलए ापस होने की
स.ं तथा िीर्भक िाने ह,ैं की संख्या, र्भ तथा िीर्भक जतजथ
(1) (2) (3) (4) (5)
1 आई एस 17717 (भाग 1) : 2023 28 ददसम्बर लागू नहीं लागू नहीं
2023
इन-ज रो डायग्नोजस्ट्िक (आई ीडी)
उपकरणों — स्ट् चाजलत जक्लजनकल
रसायन ज ज्ञान ज श्र्लेर्क
भाग 1 आर्द् भरसायन ज श्र्लेर्क
2 आई एस 17717 (भाग 2) : 2023 28 ददसम्बर लागू नहीं लागू नहीं
इन-ज रो डायग्नोजस्ट्िक (आई ीडी) 2023
66 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
क्रम स्ट्थाजपत भारतीय मानकों की संख्या, र्भ प्रजतस्ट्थापन जतजथ भारतीय मानकों, यदद ापस जलए ापस होने की
स.ं तथा िीर्भक िाने ह,ैं की संख्या, र्भ तथा िीर्भक जतजथ
(1) (2) (3) (4) (5)
उपकरणों — स्ट् चाजलत जक्लजनकल
रसायन ज ज्ञान ज श्र्लेर्क
भाग 2 िुष्क रसायन ज श्र्लेर्क
3 आई एस 17784 (भाग 2) : 2023 28 ददसम्बर लागू नहीं लागू नहीं
माप, जनयंत्रण और प्रयोगिाला उपयोग के 2023
जलए ज द्युत उपकरण — ईएमसी अपेक्षाएाँ
भाग 2 इन-ज रो डायग्नोजस्ट्िक मेजडकल
उपकरण के जलए ज िेर् अपेक्षाएाँ
(IEC 61326-2-6 : 2020, संिोजधत)
4 आई एस 18518 : 2023 28 ददसम्बर लागू नहीं लागू नहीं
बुलेि प्रजतरोधी सुरक्षा कााँच — गुण त्ता 2023
और कायभकाररता की अपेक्षाएाँ
पी रािेि, ैज्ञाजनक एफ ए ं उपमहाजनदिे क (आई िी एस, पी आर िी ए ं िी एन एम)
[ज ज्ञापन-III/4/असा./663/2023-24]
BUREAU OF INDIAN STANDARDS
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 1st January, 2024
Ref: HQ-PUB013/1/2020-PUB-BIS (763).—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 17717 (Part 1) : 2023 28 December NA NA
In-Vitro Diagnostic (IVD) Device — 2023
Automated Clinical Chemistry
Analyzer
Part 1 Wet Chemistry Analyzer
2 IS 17717 (Part 2) : 2023 28 December NA NA
In-Vitro Diagnostic (IVD) Device — 2023
Automated Clinical Chemistry
Analyzer
Part 2 Dry Chemistry Analyzer
3 IS 17784 (Part 2) : 2023 28 December NA NA
Electrical Equipment for Measurement, 2023
Control and Laboratory Use — EMC
Requirements
Part 2 Particular Requirements for[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
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)
In-vitro Diagnostic (IVD) Medical
Equipment
(IEC 61326-2-6 : 2020, MOD)
4 IS 18518 : 2023 28 December NA NA
Bullet Resistant Security Glass — 2023
Quality and Performance Requirements
P. RAJESH, Scientist F & DDG (ITS, PRT & TNM)
[ADVT.-III/4/Exty./663/2023-24]
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.