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 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष Phones : 2323 0910 व बस ईट Website : www.bis.gov.in 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 26 ददन 28/08/2017 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(11925) ISO/TR 24971:2013 [11.040.01] श षषक चचककत स उपकरण- आई एस ओ 14971 क य ग क ददश तनद श 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 : 27/09/2017
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 : 011-23230910,23068437 न ट: यह मस द ISO/TR 24971:2013 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 110002
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 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष Phones : 23230910 व बस ईट Website : www.bis.gov.in MEDICAL EQUIPMENT AND HOSPITAL PLANNING DEPARTMENT DRAFTS IN WIDE CIRCULATION Document Dispatch Advice Reference Date MHD 14/T/26 28/08/2017 Hospital Planning Sectional Committee, MHD 14. ADDRESSED TO: 1. All members of Hospital Planning Sectional Committee, MHD 14. 2. 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(11925) ISO/TR 24971:2013 [11.040.01] Medical devices Guidance on the application of ISO 14971 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: 27/09/2017 Comments if any, may please be made in the format indicated (hard copy or email) 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
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 - 110002 Email:1) hmhd@bis.gov.in 2) mhd@bis.gov.in 3) deepak@bis.gov.in Tel : 011-23230910, 23068437 Note: This draft is the adoption of ISO/TR 24971:2013, 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-110002. E mail: mhd@bis.gov.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 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(11925) ISO/TR 24971:2013 TITLE: Medical devices Guidance on the application of ISO 14971 LAST DATE OF COMMENTS: 27/09/2017 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)
Doc No.: MHD 14 (11925) ISO/TR 24971:2013 भ रत य म नक मस द च च त स उप रण- आई एस ओ 14971 प य ग च श च श Draft Indian Standard Medical devices Guidance on the application of ISO 14971 ICS 11.040.01 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 - 110002 August 2017 Price Group
Hospital Planning Sectional Committee, MHD 14 NATIONAL FOREWORD This Indian Standard which is identical with ISO/TR 24971:2007 Medical devices Guidance on the application of ISO 14971 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 Standard also exist. The corresponding Indian Standard 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 ISO 10993 (All Parts) Biological evaluation of medical devices ISO 13485: 2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes ISO 14971:2007 Medical Devices- Application of Risk management to medical devices IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance IS/ISO 10993 (All adopted Parts) Biological evaluation of medical devices IS/ISO 13485: 2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (under publication) IS/ISO 14971:2007 Medical Devices- Application of Risk management to medical devices (Under preparation) IS 13450(Part 1):2008 / IEC 60601-1(2005) Medical electrical equipment - Part 1: General requirement for basic safety and essential performance Identical for all adopted parts Identical 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:
International Standard IEC 60601 1-2 IEC 60601-2 16, IEC 62304 IEC 62366 Title Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment Medical device software Software life cycle processes Medical devices 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.