(Ministry of Consumer Affairs, Food & Public distribution, Govt. of India)

भ रत य म नक य र ) उपभ म मल,ख य एव स व ज नक वतरण म र लय,भ रत सरक र( (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष/Phones : 2323 0131 / 2323 3375 / 2323 9402 व बस ईट/Website : www.bis.org.in पक प रचलन म मस द स दभ दन क एम एच ड 15/ ट 31 & 38 08-06-2016 तकन क स म त एम एच ड 11 प न व ल क न म न तक प नज वन एवम सह यक उपकरण वषय स म त एमएचड 11 क सभ सद य क च क स उपकरण एवम अ पत ल आय जन वभ ग प रषद अ य सभ च रखन व ल मह दय, न ल खत ल ख सल ह : 1. ल ख स य : एम एच ड 11 (10343)/ आई एस/आ एस ओ 7396-1 : 2016. श ष क : च क स ग स प इपल ईन ण लय भ ग 1 स प डत च क स ग स और नव त क लए प इप ल इन ण लय (पहल प नर षण) 2. ल ख स य : एम एच ड 11 (10344)/ आई एस/आ एस ओ 5356-1 : 2015. श ष क : ए न थ टक एव सन उप कर - श क र कन टस भ ग 1 श क और स क ट (पहल प नर षण) क य इन म नक मस द क अवल कन कर और अपन स म तय यह बत त ए भ ज क अ तत य द य म नक र य म नक क प म क शत ह ज य त इन पर अमल करन म आपक वस ए अथव क र ब र म य क ठन इय आ सकत ह

भ रत य म नक य र ) उपभ म मल,ख य एव स व ज नक वतरण म र लय,भ रत सरक र( (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष/Phones : 2323 0131 / 2323 3375 / 2323 9402 व बस ईट/Website : www.bis.org.in स म तय य द क ई ह त क य अगल प पर दय गय प म अध ह त षर क उप र ल खत पत पर भ ज द स म तय भ जन क अ तम त थ : 07-08-2016 य द क ई स म त नह ह त ह अथव स म त म क वल भ ष स ब ध ट ई त उपर ल ख क यथ वत अ तम प द दय ज य ग य द क ई स म त तकन क क त क ई त वषय स म त क अ यष क पर मश स अथव उनक इ छ पर आग क क य व ह क लय वषय स म त क भ ज ज न क ब द ल ख क अ तम प द दय ज य ग ध यव द भवद य स ल क : उपर ( दल प क म र) व ञ नक एफ एव मख (एम एच ड ) ई म ल 1) sempal@bis.org.in 2) mhd@bis.org.in31t फ न : 011-23230910

भ रत य म नक य र ) उपभ म मल,ख य एव स व ज नक वतरण म र लय,भ रत सरक र( (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष/Phones : 2323 0131 / 2323 3375 / 2323 9402 व बस ईट/Website : www.bis.org.in DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE Ref Date MHD 11/T- 31 & 38 08-06-2016 TECHNICAL COMMITTEE: MHD 11 ADDRESSED TO: 1. All members of Anaesthetic, Resuscitation and Allied Equipment Sectional Committee, MHD 11 2. All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam(s)/Sir(s), Please find enclosed the following documents: 1. Doc No.: MHD 11(10343 )/ISO 7396-1 : 2016 TITLE: Medical gas pipeline system Part 1 Pipeline systems for compressed medical gases and vacuum (first revision) 2. Doc No.: MHD 11(10344)/ISO 5356-1 : 2015 TITLE: Anaesthetic & Respiratory Equipment Conical Connectors Part 1 Cones & Sockets (first revision) Kindly examine these draft standards and forward your views stating any difficulties, which you are likely to experience in your business or profession, if these are finally adopted as National Standard. Last date for comments: 07-08-2015

भ रत य म नक य र ) उपभ म मल,ख य एव स व ज नक वतरण म र लय,भ रत सरक र( (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन, 9 बह द रश ह जफर म ग, नई द ल 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष/Phones : 2323 0131 / 2323 3375 / 2323 9402 व बस ईट/Website : www.bis.org.in FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) 1. Doc No.: MHD 11(10343)/ISO 7396-1 : 2016 TITLE: Medical gas pipeline system Part 1 Pipeline systems for compressed medical gases and vacuum (first revision) 2. Doc No.: MHD 11(10344 )/ISO 5356-1 : 2015 TITLE: Anaesthetic & Respiratory Equipment Conical Connectors Part 1 Cones & Sockets (first revision) LAST DATE OF COMMENTS: 07-08-2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/ table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

Draft for Comments only Doc No.: MHD 11 (10343) IS/ISO 7396-1 : 2016 भ रत य म नक मस द च क स ग स प इपल ईन ण लय भ ग 1 स प डत च क स ग स और नव त क लए प इप ल इन ण लय (पहल प नर षण) Draft Indian Standard Medical gas pipeline system Part 1 Pipeline systems for compressed medical gases and vacuum (First Revision) ICS 11.040.10 BIS 2016 B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI 110002 June 2016 Price Group

Draft for Comments only Doc No.: MHD 11 (10343) IS/ISO 7396-1 : 2016 (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Medical gas pipeline system Part 1: Pipeline systems for compressed medical gases and vacuum (first revision) Last date of receipt of comments is 07-08-2016 Anaesthetic, Resuscitation and Allied equipment Sectional Committee, MHD 11 NATIONAL FOREWORD This draft Indian Standard (Part 1) is identical with ISO 7396-1 : 2016 Medical gas pipeline system Part 1: Pipeline systems for compressed medical gases and vacuum issued by the International Organization for Standardization (ISO) will be adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. This standard was first published in 2014 by adopting ISO 7396-1 : 2007 Medical gas pipeline system Part 1: Pipeline systems for compressed medical gases and vacuum. This first revision has been taken up to align it with the latest edition of ISO 7396-1 : 2016. Many healthcare facilities use pipeline systems to deliver medical gases and to provide vacuum to areas where they are used in patient care or to power equipment such as ventilators and surgical tools. This standard will be useful to healthcare facilities providers. The text of the ISO Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appears referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated:

International Standards Corresponding Indian Standards Degree of Equivalence ISO 8573-1 : 2010 Compressed air Part 1: Contaminants and purity classes ISO 9170-1 Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 10524-2 : 2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators ISO 15001 : 2010Anaesthetic and respiratory equipment Compatibility with oxygen IS/ISO 8573-1 : 2001 Compressed air Part 1 Contaminants and purity classes IS/ISO 9170-1 : 2008 Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum IS/ISO 10524-2 : 2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators IS/ISO 15001 : 2010 Anaesthetic and respiratory equipment Compatibility with oxygen (first revision) [Under print] Identical with ISO 5873-1 : 2001 Identical with ISO 9170-1 : 2008 Identical do The technical committee has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard Title ISO 3746 : 2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane ISO 5359 : 2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases ISO 11197 : 2004 Medical supply units ISO 14644-1:1999 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 14971 : 2007 Medical devices Application of risk management to medical devices ISO 17672 : 2010 ISO 18082 : 2014 ISO 21969 : 2009 ISO 29463-1 : 2011 ISO 80601-2-69 : 2014 Brazing Filler metals Anaesthetic and respiratory equipment Dimensions of noninterchangeable screw threaded (NIST) low-pressure connectors for medical gases High-pressure flexible connections for use with medical gas systems High-efficiency filters and filter media for removing particles in air Part 1: Classification, performance testing and marking Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

International Standard IEC 60601-1-8 : 2006 EN 286-1 : 1998 EN 1041 : 2008 EN 1254-1:1998 EN 1254-4 : 1998 EN 13348 : 2008 Title Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Simple unfired pressure vessels designed to contain air or nitrogen Part 1: Pressure vessels for general purposes Information supplied by the manufacturer of medical devices Copper and copper alloys - Plumbing fittings - Fittings with ends for capillary soldering or capillary brazing to copper tubes Copper and copper alloys - Plumbing fittings - Fittings combining other end connections with capillary or compression ends Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum Note: This draft if the adoption of ISO 7396-1 : 2016 which is available on ISO website. The technical content of the document is not available on website. For details, please contact: Head, Medical Equipment & Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi-110002 E-mail: mhd@bis.org.in

Draft for Comments only Doc No.: MHD 11 (10344) IS/ISO 5356-1 : 2015 भ रत य म नक मस द ए न थ टक एव सन उप कर - श क र कन टस भ ग 1 श क और स क ट (पहल प नर षण) Draft Indian Standard Anaesthetic & Respiratory Equipment Conical Connectors Part 1 Cones & Sockets (First Revision) ICS 11.040.10 BIS 2016 B U R E A U O F I N D I A N S T A N D A R D S MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI 110002 June 2016 Price Group

Draft for Comments only Doc No.: MHD 11(10344) IS/ISO 5356-1 : 2015 (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Anaesthetic & Respiratory Equipment Conical Connectors Part 1 Cones & Sockets (First Revision) Last date of receipt of comments is 07-08-2016 Anaesthetic, Resuscitation and Allied equipment Sectional Committee, MHD 11 NATIONAL FOREWORD This draft Indian Standard is identical with ISO 5356-1 : 2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cone and sockets issued by the International Organization for Standardization (ISO) will be adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. This standard was first published in 2012 identical to ISO 5356-1 : 2004. This revision has been taken up to aligned it with latest edition of ISO 5356-1 : 2015. In clinical practice, several breathing attachments used in anaesthetic and respiratory equipment may have to be joined together to provide a suitable breathing system. Items of medical equipment, such as a humidifier or a spirometer, are often incorporated into the breathing system which might also be connected to an anaesthetic gas scavenging system. Connections for these purposes are usually cone and socket joints, and a lack of standardization of these connections has given rise to problems of interchangeability when connecting equipment made by different manufacturers. This part of ISO 5356 specifies the requirements and dimensions for cones and sockets used in anaesthetic and respiratory equipment. An important consideration is that conical connections need to be secure but nevertheless disconnectable by the operator. The use of cones and sockets meeting the requirements of this part of ISO 5356 will not necessarily prevent them being disconnected accidentally. To minimize the risk of 22 mm connectors being accidentally disconnected, latching sockets can be used. The text of the ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appears referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 5367 : 2014 Anaesthetic and respiratory equipment Breathing sets and connectors IS/ISO 5367 : 2014 Anaesthetic and respiratory equipment Breathing sets and connectors (first revision) [Under publication] Identical The standard also makes a reference to the BIS Certification Marking of the product. Details of which is given in National Annex A. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.

NATIONAL ANNEX A (National Foreword) A-1 BIS CERTIFICATION MARKING A-1.1 The product may also be marked with the Standard Mark. A-1.1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. Note: This draft if the adoption of ISO 5356-1:2015 which is available on ISO website. The technical content of the document is not available on website. For details, please contact: Head, Medical Equipment & Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi-110002 E-mail: mhd@bis.org.in