DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE MHD 03/ T- 84,91,67,88 06/05/2015 TECHNICAL COMMITTEE: MHD 03

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1 DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 03 DOCUMENT DESPATCH ADVICE Ref Date MHD 03/ T- 84,91,67,88 06/05/2015 ADDRESSED TO: 1. All members of Obstetric And Gynaecological Instruments And Appliances Sectional Committee, MHD03 2. 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 03(0386)/ISO 7439:2015 TITLE : Copper-bearing contraceptive intrauterine devices -- Requirements and tests (First Revision) Doc No.: MHD 03(0387)/ISO 25841: 2014 TITLE : Female condoms -- Requirements and test methods Doc No.: MHD 03(0388)/ ISO 4074 : 2014 TITLE : Natural rubber latex male condoms -- Requirements and test methods (First Revision) Doc No.: MHD 03(0389)/ ISO 8009:2014 TITLE : Mechanical contraceptive Reusable natural and silicon rubber contraceptive diaphragms Requirements and test methods (First Revision) 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: 06/08/2015 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. Encl: As above Thanking you, Yours sincerely, (S. Kishore Kumar) Scientist F & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) priyankamehra@bis.org.in 2) mhd@bis.org.in Telefax:

2 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 03(0386)/ISO 7439:2015 TITLE : Copper-bearing contraceptive intrauterine devices -- Requirements and tests (First Revision) LAST DATE OF COMMENTS: 06/08/2015 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

3 Draft for Comments only Doc No.: MHD 03 (0386) ISO 7439:2015 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Copper-bearing contraceptive intrauterine devices -- Requirements and tests ( First Revision) Last date of receipt of comments is 06/08/2015 Obstetric And Gynaecological Instruments And Appliances Sectional Committee, MHD03 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 7439:2015 Copper-bearing contraceptive intrauterine devices -- Requirements and tests' issued by the International Organization for Standardization. This standard was first published in 2002 as IS/ISO 7439:2002 based on ISO 7439:2002 which has been revised in This revision is being taken to align it with the latest international practices. Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing contraceptive intrauterine devices (IUDs) function is by the continuous release of copper ions. This interferes with some enzymatic functions, immobilizes sperm cells and inhibits fertilization. These contribute to the high effectiveness of the contraception. The effectiveness of copper-bearing IUDs is many times greater than that of a simple plastics body. 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:

4 International Standards Corresponding Indian Standards Degree of Equivalence ISO , Biological IS (Part 1) : 1994 evaluation of medical devices Biological Evaluation Of (with ISO Part 1: Evaluation and testing Medical Devices Part 1 Guidance 1:1992) within a risk management On Selection Of Tests (First process Revision) ISO , Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements IS/ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( First Revision ) 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 Title ISO Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14630:2012 Non-active surgical implants General requirements ISO 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.

5 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 mhd@bis.org.in hmhd@bis.org.in

6 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 03(0387)/ISO 25841: 2014 TITLE : Female condoms -- Requirements and test methods LAST DATE OF COMMENTS: 06/08/2015 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

7 Draft for Comments only Doc No.: MHD 03 (0387) ISO 25841: 2014 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Female condoms -- Requirements and test methods Last date of receipt of comments is 06/08/15 Obstetric And Gynaecological Instruments And Appliances Sectional Committee, MHD03 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 25841: 2014 Female condoms -- Requirements and test methods' issued by the International Organization for Standardization. A female condom is a sheath that completely lines the vaginal canal and is designated to be retained in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and transmission of sexually transmitted infections (STIs). A female condom is distinguished from a male condom in that it is retained in the vagina after withdrawal of the penis. The external component of the device can provide some coverage to the external female genitalia. Non-porous, intact, polymer films can be effective barriers to human immunodeficiency virus (HIV), to other infectious agents responsible for the transmission of STls, and to spermatozoa. Female condoms made from polymer films can be effective for contraceptive purposes and in the prevention of STI transmission. To be effective, it is essential that female condoms completely line the vaginal canal, be free from holes and defects, have adequate physical properties so as not to break during use, are correctly packaged to protect them during storage, and are correctly labelled to facilitate their use. To be safe, it is essential that the female condom and any lubricant, additive, dressing, individual packaging material, or powder applied to it neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating, or otherwise harmful under normal conditions of storage or use. 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.

8 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 :1999, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4074, Natural rubber latex male condoms Requirements and test methods ISO , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements IS 2500 (Part 1) : 2000 Sampling Procedure For Inspection By Attributes Part 1 Sampling Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection (Third Revision) 1S/1S : 2002 Natural Latex Rubber Condoms - Requirements and Test Methods IS (Part 1) : 1994 Biological Evaluation Of Medical Devices Part 1 Guidance On Selection Of Tests (First Revision) IS/ISO 13485: 2003 Medical Devices Quality Management Systems Requirements For Regulatory Purposes IS/ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements (First Revision ) (with ISO :1992) 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 ISO ISO ISO (all parts) Title Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization Biological evaluation of medical devices Part 11: Tests for systemic toxicity Clinical investigation of medical devices for human subjects

9 ISO ISO (Part 2) Medical devices Application of risk management to medical devices Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation 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.

10 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 mhd@bis.org.in hmhd@bis.org.in

11 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 03(0388)/ ISO 4074 : 2014 TITLE: Revision) Natural rubber latex male condoms -- Requirements and test methods (First LAST DATE OF COMMENTS: 06/08/2015 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

12 Draft for Comments only Doc No.: MHD 03 (0388) ISO 4074 : 2014 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Natural rubber latex male condoms -- Requirements and test methods (First Revision) Last date of receipt of comments is 06/08/15 Obstetric and Gynaecological Instruments and Appliances Sectional Committee, MHD03 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 4074 : 2014 Natural rubber latex male condoms - Requirements and test methods' issued by the International Organization for Standardization. This standard was first published in 2002 as IS/ISO 4074:2002 based on ISO 4074:2002 which has been revised in This revision is being taken to align it with the latest international practices. Condoms made from intact latex film have been shown to be a barrier to human immunodeficiency virus (HIV), other infectious agents responsible for the transmission of sexually transmitted infections (STIs) and to spermatozoa. Numerous clinical studies have confirmed that male latex condoms are effective in helping to prevent pregnancy and reduce the risk of transmission of most STIs including HIV. In order to help ensure that condoms are effective for contraceptive purposes and in assisting in the prevention of transmission of STIs, it is essential that condoms fit the penis properly, are free from holes, have adequate physical strength so as not to break during use, are correctly packaged to protect them during storage and are correctly labelled to facilitate their use. Condoms are medical devices. To ensure high quality product, it is essential that condoms are produced under a good quality management system. Condoms are nonsterile medical devices but manufacturers are advised to take appropriate precautions to minimize microbiological contamination of the product throughout the manufacturing and packaging processes. 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.

13 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 , Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO , Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories IS 2500 (Part 1) : 2000 Sampling Procedure For Inspection By Attributes Part 1 Sampling Schemes Indexed By Acceptance Quality Limit (AQL) For Lot- By-Lot Inspection (Third Revision) IS (Part 1) : 1994 Biological Evaluation Of Medical Devices Part 1 Guidance on Selection of Tests (First Revision) IS/ISO : 2012 Medical Devices Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( First Revision ) IS/ISO/IEC : 2005 General Requirements For The Competence of Testing and Calibration Laboratories ( First Revision) (with ISO :1992) 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 Title Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

14 ISO ISO Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation 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.

15 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 mhd@bis.org.in hmhd@bis.org.in

16 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 03(0389)/ ISO 8009:2014 TITLE : Mechanical contraceptive Reusable natural and silicon rubber contraceptive diaphragms Requirements and test methods (First Revision) LAST DATE OF COMMENTS: 06/08/2015 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

17 Draft for Comments only Doc No.: MHD 03 (0389) ISO 8009:2014 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Mechanical contraceptive Reusable natural and silicon rubber contraceptive diaphragms Requirements and test methods (First Revision) Last date of receipt of comments is 06/08/15 Obstetric And Gynaecological Instruments And Appliances Sectional Committee, MHD03 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 8009:2014 Mechanical contraceptive Reusable natural and silicon rubber contraceptive diaphragms Requirements and test methods issued by the International Organization for Standardization. This standard was first published in 2004 as IS/ISO 8009:2004 based on ISO 8009:2004 which has been revised in This revision is being taken to align it with the latest international practices. Diaphragms are medical devices, therefore, they should be produced under a good quality management system. Reference should be made, for example to the IS/ISO 9000 series, in conjunction with IS/ISO The sampling plans and acceptance quality limits (AQLs) given in this Indian Standard are for referee testing. The AQLs represent the maximum tolerable level of defects in the products. As diaphragms are intended for re-use, manufacturers should strive for entirely defect-free product. Manufacturers can devise and apply additional and alternative quality control measures for their use and after production. These methods can differ among manufacturers 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.

18 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 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ISO 463, Geometrical Product Specifications (GPS) Dimensional measuring equipment Design and metrological characteristics of mechanical dial gauges ISO :1999, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process IS 3400 (Part 4) : 2012 Methods of Test for Vulcanized Rubber Part 4 Accelerated Ageing and Heat Resistance ( Third Revision ) IS 2092:1983 Specification for Plunger Type Dial Gauges (First Revision) IS 2500 (Part 1) :2000 Sampling Procedure For Inspection By Attributes Part 1 Sampling Schemes Indexed By Acceptance Quality Limit (Aql) For Lot-By- Lot Inspection ( Third Revision) IS (Part 1) : 1994 Biological Evaluation Of Medical Devices Part 1 Guidance On Selection Of Tests (First Revision) Technical Equivalent Technical Equivalent (with ISO :1992) 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 ISO Title Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization 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.

19 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 mhd@bis.org.in hmhd@bis.org.in