च क त स उप रण एव अस पत ल य जन ववभ ग डडकल डड इस स फ ट यर - स फ ट यर ज न चक कक य ए

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1 भ रत य म नक ब य र (उपभ क म मल, ख़ द एव स वजन क नवतरण म त लय,भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन,9 बह द रश ह जफर म र ग, नई ददल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : व बस ईट Website : व य प परर लन म मस द च क त स उप रण एव अस पत ल य जन ववभ ग स दभभ एम ए ड 14/ ट 29 ददन 01/09/2017 त न सममतत अस पत ल य जन व षय सम तत ए एच ड 14 प न व ल न म अस पत ल य जन व षय सम तत ए.एच.ड 14, क सभ सदस य क चचककत स उपकरण ए अस पत ल य जन व भ ग पररषद अन य सभ चच रखन ल व य ह दय/ ह दय, तनम नमलखखत ल ख स लग न ह : क स ल ख स ख य 1. ल ख स ख य ए एच ड 14 (11941) ISO : 2015 श षषक डडकल डड इस स फ ट यर - स फ ट यर ज न चक कक य ए क पय इस नक स द क अ ल कन कर और अपन सम ततय यह बत त ह ए भ ज कक अ तत यदद यह नक र ष र य नक क प क मशत ह ज ए त इन पर अ ल करन आपक व य स ए अथ क र ब र क य कद न इय आ सकत ह सम ततय यदद क ई ह त क प य अगल प ष ट पर ददय गय पत अध हस त क र क उपररमलखखत पत पर भ ज द ( ह डष क प य ई ल द र ) सम ततय भ जन कक अ तत ततचथ : 30/09/2017

2 यदद क ई सम तत प त नह ह त ह अथ सम तत क ल भ ष स ब चध त दट ह ई त उपर क त ल ख क यथ त अ तत प द ददय ज य ग यदद क ई सम तत तकन क क तत क ह ई त व षय सम तत क अध यक क पर शष स अथ उनक इच छ पर आग क क यष ह क मलय व षय सम तत क भ ज ज न क ब द ल ख क अ तत प द ददय ज य ग धन य द भ द य स लग क : र क ( क श बच न ) ज तनक ई ए ख (ए एच ड ) म ल 1) hmhd@bis.gov.in 2) mhd@bis.gov.in 3) deepak@bis.gov.in न : , न ट: यह मस द ISO : 2015 अड प शन ह, ज क आई एस ओ व बस इट पर उपलब ध ह ईस ट क नन ल ट ट मलए पय स प भ र : प म ख, च क त स उप रण एव अस पत ल य जन ववभ ग, भ रत य म न ब य र, 9 बह द रश ह जफर म गभ, नई ददल ल

3 भ रत य म नक ब य र (उपभ क म मल, ख़ द एव स वजन क नवतरण म त लय,भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन,9 बह द रश ह जफर म र ग, नई ददल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : व बस ईट Website : MEDICAL EQUIPMENT AND HOSPITAL PLANNING DEPARTMENT DRAFTS IN WIDE CIRCULATION Document Dispatch Advice Reference Date MHD 14/T/29 01/09/2017 Hospital Planning Sectional Committee, MHD 14. ADDRESSED TO: 1. All members of Hospital Planning Sectional Committee, MHD All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Sir(s)/Madam(s), Please find enclosed the following document: Sl. No. Doc. No. Title 1. MHD 14 (11941) ISO : 2015 Medical device software Software life cycle processes Kindly examine the draft standard and forward your views stating any difficulties, which you are likely to experience in your business or profession, if this is finally adopted as National Standard. Last date for comments: 30/09/2017 Comments if any, may please be made in the format indicated (hard copy or ) and mailed to the undersigned at the above address. In case no comments are received or comments received are of editorial nature, you will kindly permit us to presume your approval for the above document as finalized. However, in case comments of technical nature are received then it may be finalized either in consultation with the Chairman, Sectional Committee or referred to the

4 Sectional committee for further necessary action if so desired by the Chairman, Sectional Committee. Thanking you, Yours sincerely, Encl: As above ( Prakash Bachani) Scientist E & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) hmhd@bis.gov.in 2) mhd@bis.gov.in 3) deepak@bis.gov.in Tel : , Note: This draft is the adoption of ISO : 2015, which is available on the ISO website. For the technical content of the above document, please contact: Head, Medical Equipment & Hospital Planning Department, Bureau of Indian Standards, 9, Bahadur Shah Zafar Marg, New Delhi E mail: mhd@bis.gov.in

5 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 to be started in a fresh box. Information in Column 5 should include reasons for the comments and suggestions for modified wording of the clauses should be typed in Column 6 when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) Doc. No.: MHD 14 (11941) ISO : 2015 TITLE: Medical device software Software life cycle processes LAST DATE OF COMMENTS: 30/09/2017 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. (1) Clause/Sub-clause/ para/table/fig. No. commented (2) Commentator/ Organization/ Abbreviation (3) Type of Comments (General/Editorial/ Technical) (4) Justification (5) Proposed change (6)

6 Doc No.: MHD 14 (11941) ISO : 2015 भ रत य म नक मस द म ड कल ड व इस स फ टव यर - स फ टव यर ज वन चक प डक य ए Draft Indian Standard Medical device software Software life cycle processes ICS BIS 2017 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 August 2017 Price Group

7 Hospital Planning Sectional Committee, MHD 14 NATIONAL FOREWORD This Indian Standard which is identical with ISO : 2015 Medical device software Software life cycle processes issued by the International Organization for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee MHD 14 and approval of the Medical Equipment and Hospital Planning Division Council. The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear 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 the following International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their place are listed below along with their degree of equivalence for the edition indicated: International Standard Corresponding Indian Standard Degree of Equivalence IEC : 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC : 2005/AMD1:2012 IEC : 2010 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements ISO : ) Medical devices Quality management systems Requirements for regulatory purposes 1) Revised in 2016 IS (Part 1)/IEC : 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (second revision) [under publication] IS/IEC : 2010 Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General Requirement IS/ISO : 2016 Medical devices- Quality management systems- Requirements for Regulatory purposes. (under publication) Identical with IEC : 2005 Ed Amd 1/2012 Identical Identical The technical committee responsible for the preparation of this standard reviewed the provisions of following International Standard(s) referred in this adopted standard and has decide that it is acceptable for use in conjunction with this standard:

8 International Standard Title IEC IEC ISO 9000:2005 ISO 9001 : 2008 ISO/IEC :2001 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Functional safety of electrical/electronic/programmable electronic safety related systems Part 3: Software requirements Quality management systems Fundamentals and vocabulary Quality management systems Requirements Software engineering Product quality Part 1: Quality model ISO/IEC : , ISO/IEC : 1999 ISO/IEC : 2012 ISO/IEC : 2011 IEC : 3) ISO/IEC : 2) ISO/IEC : 2) ISO/IEC : 2014 ISO/IEC Guide 51 : 2014 IEEE : 1990 IEEE 1044 : 2009 IEC :2015 Information technology Systems and software engineering Software life cycle processes Amendment 1 (2002) Amendment 2 (2004) Information technology Software maintenance Software Engineering Software Life Cycle Processes Maintenance Information technology Process assessment Part 5: An exemplar software life cycle process assessment model Systems and software engineering System and software Quality Requirements and Evaluation (SQuaRE) System and software quality models Healthcare Software Systems Part 1: General requirements Information technology Process assessment Concepts and terminology Information technology Process assessment Requirements for process reference, process assessment and maturity models Software engineering Guidelines for the application of ISO 9001: to computer software Safety aspects Guidelines for their inclusion in standards IEEE standard glossary of software engineering terminology IEEE standard classification for software anomalies Medical devices Part 1: Application of usability engineering to medical devices 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 or analysis, 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.