Executive Summary:
This document comprises two notifications from the Bureau of Indian Standards, Ministry of Consumer Affairs, Food and Public Distribution, regarding the establishment and cancellation of Indian Standards. The notifications, dated August 28, 2017, specify the new standards established, their effective dates, and the concurrent standards that will be cancelled by February 25, 2018, and March 1, 2019. These notifications are issued in pursuance of the Bureau of Indian Standards Rules, 1987.
Key Points / Main Content:
Notification 1 (S.O. 2923E):
* **Establishment of New Standards:**
* IS 3470: 2017 (Hexane, Food Grade Specification Second Revision) established on August 26, 2017.
* IS 4923: 2017 (Hollow Steel Sections for Structural Use Specification Third Revision) established on August 26, 2017.
* IS 5430: 2017 (Ammonia Preserved Concentrated Natural Rubber Latex Second Revision) established on August 26, 2017.
* **Concurrent Standards to be Cancelled:**
* IS 3470: 2002 (Hexane, Food Grade Specification First Revision) to be cancelled on February 25, 2018.
* IS 4923: 1997 (Hollow Steel Sections for Structural Use Specification Second Revision) to be cancelled on February 25, 2018.
* IS 5430: 1981 (Ammonia Preserved Concentrated Natural Rubber Latex First Revision) to be cancelled on February 25, 2018.
Notification 2 (S.O. 2924 E):
* **Establishment of New Standards:**
* ISISO 13485: 2016 (Medical Devices Quality Management Systems Requirements for Regulatory Purposes First Revision) established on August 26, 2017.
* **Concurrent Standards to be Cancelled:**
* ISISO 13485: 2003 (Medical Devices Quality Management Systems Requirements for Regulatory Purposes) to be cancelled on March 1, 2019.
Availability of Standards:
* Copies of these standards are available for sale at the Bureau of Indian Standards offices and online.
Impact Analysis:
Manufacturers and Producers:
* Impact: Must adhere to the updated standards for Hexane (Food Grade), Hollow Steel Sections, Ammonia Preserved Concentrated Natural Rubber Latex, and Medical Devices Quality Management Systems.
* Action Required: Update manufacturing processes and product specifications to comply with the new standards (IS 3470: 2017, IS 4923: 2017, IS 5430: 2017 and ISISO 13485: 2016) before the cancellation of the previous standards.
Bureau of Indian Standards:
* Impact: Responsible for implementing and enforcing the new standards and cancelling the old standards.
* Action Required: Ensure the availability of the updated standards for sale and provide guidance to stakeholders on compliance.
Consumers:
* Impact: Benefit from products that meet updated safety and quality standards.
* Action Required: Be aware of the updated standards and look for products that comply with them.
Regulatory Bodies:
* Impact: Must update regulations to reflect the new standards.
* Action Required: Incorporate the new standards into regulatory frameworks and ensure compliance through audits and inspections.
Key Entities Referenced
Bureau of Indian Standards: A national standards body of India responsible for formulating and promoting standards.
Bureau of Indian Standards Rules, 1987: The rule under which the Bureau of Indian Standards notifies Indian Standards.
Ministry of Consumer Affairs, Food and Public Distribution: The Indian government ministry responsible for consumer affairs, food, and public distribution.
Department of Consumer Affairs: A department within the Ministry of Consumer Affairs, Food and Public Distribution.
New Delhi: The capital city of India, where the notification is issued.
IS 3470 : 2017: Indian Standard for Hexane, Food Grade Specification (Established in 2017).
IS 4923 : 2017: Indian Standard for Hollow Steel Sections for Structural Use Specification (Established in 2017).
IS 5430 : 2017: Indian Standard for Ammonia Preserved Concentrated Natural Rubber Latex (Established in 2017).
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1. आई एस 3470 : 2017 ह.े सन, खाध 26 अग(cid:11)त 2017 आई एस 3470 : 2002 ह.े सन, 25 फरवरी 2018
/ेड – िविशि1 (दसू रा पुनरी2ण) खाध /ेड – िविशि1 (पहला
पुनरी2ण)
2. आई एस 4923 : 2017 खोखले इ(cid:11)पात 26 अग(cid:11)त 2017 आई एस 4923 : 1997 खोखले 25 फरवरी 2018
के ख4ड रचना5मक 6योग के िलए – इ(cid:11)पात के ख4ड रचना5मक 6योग
िविशि1 (तीसरा पुनरी2ण) के िलए – िविशि1 (दसू रा
पुनरी2ण)
5533 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
3. आई एस 5430 : 2017 अमोिनया 26 अग(cid:11)त 2017 आई एस 5430 : 1981 25 फरवरी 2018
प7ररि2त सां(cid:4)8त 6ाकृितक रबड़ लैट.े स अमोिनया प7ररि2त सां(cid:4)8त
(दसू रा पुनरी2ण) 6ाकृितक रबड़ लैटे.स (पहला
पुनरी2ण)
इस भारतीय मानक क= 6ितय> भारतीय मानक (cid:19)यूरो, मानक भवन, 9, बहादरु शाह ज़फर माग,A नई (cid:4)द(cid:6) ली 110 002 2ेBीय कायाAलय& :
नई (cid:4)द(cid:6)ली, कोलकता, चंडीगढ़, चेCई, मुंबई, तथा शाखा कायाAलय&: अहमदाबाद, बंगलौर, भोपाल, भुवनेEर, कोयंबतूर, गुवाहाटी,
हदै राबाद, जयपुर, पटना, नागपुर, पूणे तथा कोिच म(cid:30) िबF= हते ु उपल(cid:19)ध ह।) भारतीय मानक& को http://www.standardsbis.in (cid:31)ारा
इंटरनैट पर खरीदा जा सकता ह )।
[संदभA: PUB/3/2/2017-18]
सी.बी. Iसह, अपर महािनदशे क
MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
(BUREAU OF INDIAN STANDARDS)
NOTIFICATION
New Delhi, the 28th August, 2017
S.O. 2923(E).—In pursuance of clause (b) of sub-rule (1) of Rule 7 of the Bureau of Indian Standards Rules,
1987, the Bureau of Indian Standards hereby notifies that the Indian Standards, particulars of which are given in the
second column of schedule hereto annexed has 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 cancelled on the date indicated against them in the fifth column.
SCHEDULE
SL. No. & Year of the Indian Date of No. & Year of the Indian Date of
No. Standards Established Standards to be cancelled, cancellation
Establishment
if any
(1) (2) (3) (4) (5)
1. IS 3470 : 2017 Hexane, Food Grade 26 Aug 2017 IS 3470 : 2002 Hexane, Food 25 Feb 2018
– Specification (Second Revision) Grade – Specification (First
Revision)
2. IS 4923 : 2017 Hollow Steel 26 Aug 2017 IS 4923 : 1997 Hollow Steel 25 Feb 2018
Sections for Structural Use – Sections for Structural Use –
Specification (Third Revision) Specification (Second
Revision)
3. IS 5430 : 2017 Ammonia Preserved 26 Aug 2017 IS 5430 : 1981 Ammonia 25 Feb 2018
Concentrated Natural Rubber Latex Preserved Concentrated
(Second Revision) Natural Rubber Latex (First
Revision)¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
Copies of these standards are available for sale with Bureau of Indian Standards, Manak Bhawan, 9 Bahadur Shah Zafar
Marg, New Delhi-110002 ; Regional Offices: Kolkata, Chandigarh, Chennai, Mumbai and Branch Offices: Ahmedabad,
Bengaluru, Bhopal, Bhubaneshwar, Coimbatore, Guwahati, Hyderabad, Jaipur, Nagpur, Patna, Pune, Kochi. Online
purchase of Indian Standards can be made at http://www.standardsbis.in.
[Ref: PUB/3/2/2017-18]
C.B. SINGH, Addl. Director General
अअअअििििधधधधससससूचूचूचूचननननाााा
नई (cid:4)द(cid:6) ली, 28 अग(cid:11)त 2017
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अअअअननननुसुसुसुसचचूूचचूू ीीीी
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1. आई एस/आई एस ओ 13485 : 2016 26 अग(cid:11)त 2017 आई एस/आई एस ओ 13485 : 1 माचA 2019
िच(cid:4)क5सा साधन – गुणता 6बंध तंB – 2003 िच(cid:4)क5सा साधन – गुणता
िनयामक उदKे य& के िलये अपे2ाएं 6बंध तंB – िनयािमक उदKे य& के
(पहला पुनरी2ण)
िलये अपे2ाएं
इस भारतीय मानक क= 6ितय> भारतीय मानक (cid:19)यूरो, मानक भवन, 9, बहादरु शाह ज़फर माग,A नई (cid:4)द(cid:6) ली 110 002 2ेBीय कायाAलय& :
नई (cid:4)द(cid:6)ली, कोलकता, चंडीगढ़, चेCई, मुंबई, तथा शाखा कायाAलय&: अहमदाबाद, बंगलौर, भोपाल, भुवनेEर, कोयंबतूर, गुवाहाटी,
हदै राबाद, जयपुर, नागपुर, पटना, पूणे तथा कोिच म(cid:30) िबF= हते ु उपल(cid:19)ध ह।) भारतीय मानक& को http://www.standardsbis.in (cid:31)ारा
इंटरनैट पर खरीदा जा सकता ह )।
[संदभA: PUB/3/2/2017-18]
सी.बी. Iसह, अपर महािनदशे क
NOTIFICATION
New Delhi, the 28th August, 2017
S.O. 2924 (E).—In pursuance of clause (b) of sub-rule (1) of Rule 7 of the Bureau of Indian Standards Rules,
1987, the Bureau of Indian Standards hereby notifies that the Indian Standards, particulars of which are given in the
second column of schedule hereto annexed has 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 cancelled on the date indicated against them in the fifth column.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
SCHEDULE
SL. No. & Year of the Indian Date of No. Year & Title of the Date of
No. Standards Established Establishment Indian Standards to be cancellation
cancelled, if any
(1) (2) (3) (4) (5)
1. IS/1SO 13485 : 2016 Medical 26 August 2017 IS/ISO 13485 : 2003 1 March 2019
Devices – Quality Management Medical Devices – Quality
Systems – Requirements for Management Systems –
Regulatory Purposes (First Requirements for
Revision) Regulatory Purposes
Copies of these standards are available for sale with Bureau of Indian Standards, Manak Bhawan, 9 Bahadur Shah Zafar
Marg, New Delhi-110002 ; Regional Offices: Kolkata, Chandigarh, Chennai, Mumbai and Branch Offices: Ahmedabad,
Bengaluru, Bhopal, Bhubaneshwar, Coimbatore, Guwahati, Hyderabad, Jaipur, Nagpur, Patna, Pune, Kochi. Online
purchase of Indian Standards can be made at http://www.standardsbis.in.
[Ref.: PUB/3/2/2017-18]
C.B. SINGH, Addl. Director General
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.