म नक भवन,9 बह द रश ह जफर म र ग, नई ददल ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi

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1 भ रत य म नक ब य र लम म भ भपउ (,एव स वजन क नवतरण भ त पय,म 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 : DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 19 DOCUMENT DESPATCH ADVICE Ref Date MHD 19/ T- 13,28,25,35,26,41,40 07/08/18 ADDRESSED TO: 1. All members of Immuno-Biological Diagnostic Kits Sectional Committee, MHD All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the following documents: DOC NO: MHD 19(12940)/ISO :2016 TITLE : Biological Part 6: Tests for local effects after implantation Kindly examine the draft standard 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: 06/09/18 Comments if any, may please be made in the format indicated 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. Note: adoption does not have any framework for incorporation of changes. Thanking you, Yours sincerely, Encl: As above (Prakash Bachani) Scientist E & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) 2) Telefax:

2 भ रत य म नक ब य र ( लम म भ भपउ,एव स वजन क नवतरण भ त पय,म 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 पक पर चलन स द स दर ष ए एच ड 19/ ट 13,28,25,35,26,41,40 ददन क 07/08/18 तकन क सम तत एम एच ड 19 प न व ल क न इम य न ज व क ननद न ककट व षयसममन, एम.एच.ड 19 क सभ सदस य चचककत स उपकरण ए म अस प ल आय जन व भ ग पररषद अन य सभ चच रखन ल व य मह दय मह दय /, ननम नमलखख ल ख सलग न ह 1. प ल ख सख य ए एच ड 19 (12940) आईएसओ :2016 श र षक :चचककत स उपकरण क ज व क म लय कन भ ग 6 आर पण क ब द स थ न य भ क मलए पर क ण क प य इन म नक मस द क अ ल कन कर और अपन सम मन य यह ब ह ए भ ज कक अ यदद य म नक र ष र य म नक क प म क म ह ज य इन पर अमल करन म आपक व य स ए अथ क र ब र म क य कद न इय आ सक ह सम मन य यदद क ई ह क प य अगल प ष ट पर ददय गय पत म अध हस क र क उपररमलखख प पर भ ज द सम मन य भ जन कक अ न म न चथ :06/09/18

3 यदद क ई सम मन प नह ह ह अथ सम मन म क ल भ ष स ब चध त दट ह ई उपर क ल ख क यथ अ न म प द ददय ज य ग यदद क ई सम मन कन क क न क ह ई व षय सममन क अध यक क पर म श स अथ उनक इच छ पर आग क क यश ह क मलय व षय सममन क भ ज ज न क ब द ल ख क अ न म प द ददय ज य ग धन य द भ द य ( क बच न ) ज ननक ई ए मख ) एम एच ड ( स लग नक : उपर क ईम ल1) 2) फ न :

4 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) DOC NO: MHD 19(12940)/ISO :2016 TITLE : Biological Part 6: Tests for local effects after implantation LAST DATE OF COMMENTS: 05/09/18 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

5 Draft for Comments only Doc No: MHD 19 (12940) ISO :2016 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Biological Part 6 Tests for local effects after implantation Last date of receipt of comments is 05/09/18 Biological and Clinical Evaluation of Medical Devices and Immuno-Biological Diagnostic Kits Sectional Committee, MHD 19 NATIONAL FOREWORD This Indian Standard is identical with ISO :2016 'Biological evaluation of medical devices Part 6: Tests for local effects after implantation' issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on the recommendation of the Biological and Clinical Evaluation of Medical Devices and Immuno- Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. The text of 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 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 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 , Biological Part 1: Evaluation and testing within a risk management process ISO , Biological Part 2: Animal welfare requirements IS/ISO : 2009 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing Within a Risk Management Process Doc. No.: MHD 19(271) /ISO :2006 Biological evaluation of medical devices- Part 2: Animal welfare requirements (under publication)

6 ISO , Biological Part 4: Selection of tests for interactions with blood ISO , Biological Part 12: Sample preparation and reference materials ISO , Biological Part 16: Toxicokinetic study design for degradation products and leachables IS 12572(Part 14):2016 /ISO :2002Biological evaluation of medical devices - Part 14: Selection of tests for interactions with blood (First Revision) Doc. No.: MHD 19 (288) / ISO :2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (Under Publication) MHD 19(0449)/ISO :2010 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables (Under Publication) In reporting the result of a test or analysis made in accordance with this standard, is to be rounded off, it shall be done in accordance with IS 2: 1960 'Rules for rounding off numerical values (revised)'

7 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi