TITLE : Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process

Transcription

1 DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 19 DOCUMENT DESPATCH ADVICE Ref Date MHD 19/ T- 1,2,12,13,14 12/07/2012 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(270)/ ISO :2009 TITLE : Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process DOC NO: MHD 19(271)/ISO :2006 TITLE : Biological evaluation of medical devices-part 2: Animal welfare requirements DOC NO: MHD 19(272)/ISO :2003 TITLE : Biological evaluation of medical devices-part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity DOC NO: MHD 19(273)/ISO :2002 TITLE : Biological evaluation of medical devices-part 4: Selection of tests for interactions with blood DOC NO: MHD 19(274)/ISO :2009 TITLE : Biological evaluation of medical devices-part 5: Tests for in vitro cytotoxicity 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: 15/10/2012 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

2 Chairman, Sectional Committee or referred to the Sectional committee for further necessary action if so desired by the Chairman, Sectional Committee. Encl: As above Thanking you, Yours sincerely, (Rakesh Kumar) Scientist F & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) anurita@bis.org.in 2) mhd@bis.org.in Telefax:

3 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: TITLE : LAST DATE OF COMMENTS: 15/10/2012 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

4 Draft for Comments only Doc No: MHD 19(270) ISO :2009 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process (second revision) Last date of receipt of comments is 15/10/2012 Immuno-Biological Diagnostic Kits Sectional Committee, MHD 19 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process issued by the International Organization for Standardization. This draft Indian standard was first published in 1988 based on BS 5736: Part 1: 1979 Evaluation of medical devices for biological hazards: Part 1 Guide for the selection of biological methods of test, issued by the British Standards Institution, UK. Consequent upon the publication of IS l: 1992, the Committee felt the necessity of revising this standard(first revision) to align its requirements with the latest international practices. ISO :1992 has been revised in This (second) revision is being taken to align it with the latest international practices. The primary aim of this part of ISO is the protection of humans from potential biological risks arising from the use of medical devices. It is complied from numerous international and National Standards and Guidelines concerning the biological evaluation of medical device. It is intended to be a guidance document for the biological evaluation of medical devices within a risk management process, as part of the overall evaluation and development of each device. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a dull evaluation to be made of the biological responses to each medical device, relevant to its safety in use. It must be appreciated that the term medical device is wide-ranging and, at one extreme, consists of a single material, which may exist in more than one physical form, and at the other extreme, of a complex instrument or piece of apparatus, consisting of numerous components made of more than one material.

5 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 :2006 Biological evaluation of medical devices-part 2 Animal welfare requirements ISO :2003 Biological evaluation of medical devices-part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO :2002 Biological evaluation of medical devices-part 4: Selection of tests for interaction with blood IS (Part 2): 1994 Biological evaluation of medical devices Part 2 Animal welfare requirements IS (Part 13): 1994 Biological evaluation of medical devices Part 13 Tests for geno-toxicity, carcinogenicity and reproductive toxicity IS (Part 14): 1994 Biological evaluation of medical devices Part 14 Selection of tests for interactions with blood Technically Equivalent do do The technical committee responsible for the preparation of this standard 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 ISO : 2009 ISO : 2007 ISO :2008 Title Biological evaluation of medical devices-part 5: Tests for in vitro cytotoxicity Biological evaluation of medical devices-part 6: Tests for local effects after implantation Biological evaluation of medical devices-part 7: Ethylene

6 oxide sterilization residuals ISO :2009 ISO : 2010 ISO :2006 ISO :2007 Biological evaluation of medical devices-part 9: Framework for identification and quantification of potential degradation products Biological evaluation of medical devices-part 10: Tests for irritation and skin sensitization Biological evaluation of medical devices-part 11: Tests for systemic toxicity Biological evaluation of medical devices-part 12 Sample preparation and reference materials ISO :2010 Biological evaluation of medical devices-part 13 Identification and quantification of degradation products from polymeric medical devices ISO :2001 Biological evaluation of medical devices-part 14: Identification quantification of degradation products from ceramics ISO :2000 Biological evaluation of medical devices-part 15: Identification quantification of degradation products from metals and alloys ISO :2010 Biological evaluation of medical devices-part 16: Toxic kinetic study design for degradation product and leachables ISO :2002 Biological evaluation of medical devices-part 17: Establishment of allowable limits for leachable substances ISO :2005 Biological evaluation of medical devices-part 18, Chemical, characterization and topographical characterization of materials ISO :2006 ISO/TS :2006 Biological evaluation of medical devices- Part 19: Physicochemical, morphological and topographical characterization of materials Biological evaluation of medical devices-part 20: Principles and methods for immunotoxicology testing of medical devices

7 ISO 14971:2007 Medical Devices-Application of risk management 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 same as that of the specified value in this standard.