भ रत य म नक ब य र (उपभ क त म मल, ख द य एव स वजन क नवतरण म त र लय, भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म क भव, 9 बह द रश ह जफर म र व, ई नदल ल 110002 Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi - 110002 द रभ ष Phones : 2323 0131 / 2323 3375 / 2323 9402 व बस ईट Website : www.bis.org.in व य पक पररचलन तकन क सम मत ए एच ड 06 प न व ल क न स दभज ए एच ड 06/ र 68 ( IS/ISO 5840-3:2013) थ र मसक और क र डडय व स क लर सर जर उपकरण सम मत, ए.एच.ड 06 क सभ सदस य मचककत स उपकरण एव अस पत ल आय र न मवभ ग पररषद अन य सभ र मच रखन व ल म य ह दय/ ह दय, कदन क 04.01.2019 क पय मनम नमलमखत दस त व र स लग न ह : 1. ल ख स.: ए एच ड 06 (13463) /IS/ISO 5840-3:2013 [ICS 11.040.40] श षजक : भ रत य नक स द : क र डडय व स क लर त य र पण - क र डडएकव ल व क म अ ग - भ ग 3: ह र ज व ल व मवकल प द व र त य र मपत ट सक थ र र तकन क क प य इस स द क अवल कन कर और अपन सम मतय यह बत त ह ए भ र कक अ तत यकद यह स द नक क र प क मशत ह र य त इस पर अ ल करन आपक व यवस ए अथव क र ब र क य कर न इय आ सकत ह सम मतय यकद क ई ह त क प य अगल प ष ट पर कदय गय प अध हस त क षर क उपररमलमखत पत पर भ र द सम मतय भ र न कक अ मत मतमथ : 03.02.2019 ह यकद क ई सम मत प त नह ह त ह अथव सम मत क वल भ ष स ब मध रर ह ई त उपर क त ल ख क यथ वत अ मत र प द कदय र य ग यकद क ई सम मत तकन क क मत क ह ई त मवषय सम मत क अध यक ष क पर शज स अथव उनक इच छ पर आग क क यजव ह क मलय मवषय सम मत क भ र र न क ब द ल ख क अ मत र प द कदय र य ग धन यव द स लग नक : उपर क त भवद य ( क श बच न ) ख (ए एच ड ) ई ल : hmhd@bis.org.in; mhd@bis.org.in फ न : 011-23230910
DRAFT IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE Ref Date TECHNICAL COMMITTEE: MHD 06 ADDRESSED TO: MHD 06/T- 68 ( IS/ISO 5840-3:2013) 04.01.2019 1. All members of Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHD 06 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 document: 1. Doc No.: MHD 06 (13463)/IS/ISO 5840-3:2013 [ICS 11.040.40] TITLE: Draft Indian Standard on Cardiovascular implants Cardiac valve prostheses-part 3: Heart valve substitutes implanted by trans-catheter techniques 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: 03.02.2019 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. Thanking you, Yours sincerely, Encl: As above (Prakash Bachani) Head (MHD) Bureau of Indian Standards Manak Bhawan 9, B S Z Marg, New Delhi - 110002 Email: hmhd@bis.org.in; mhd@bis.org.in: Phone: 011-23230910
BUREAU OF INDIAN STANDARDS DRAFT IN WIDE CIRCULATION FOR COMMENTS ONLY (Not to be reproduced without permission of BIS or used as standard) Doc: MHD 06 (13463) IS/ISO 5840-3:2013 (Superseding IS/ISO 5840:2005) भ रत य नक स द क र डडय व स क लर त य र पण - क र डडएकव ल व क म अ ग - भ ग 3: ह र ज व ल व मवकल प द व र त य र मपत ट सक थ र र तकन क DRAFT INDIAN STANDARD Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by Trans-catheter techniques ICS 11.040.40 BIS 2018 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 January 2019 Price Group
Doc: MHD 06 (13463) IS/ISO 5840-3:2013 (Superseding IS/ISO 5840:2005) DRAFT INDIAN STANDARD Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by Trans-catheter techniques Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHD06 NATIONAL FOREWORD This Indian Standard (Part31) which is identical with ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses-part 3: Heart valve substitutes implanted by Trans-catheter techniques issued by the International Organization for Standardization (ISO) will be adopted by the Bureau of Indian Standards on the recommendation of the Thoracic And Cardiovascular Surgery Instruments Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. This standard was first published in 2011 which was identical with ISO 5840:2005 Cardiovascular Implants Cardiac Valve Prostheses. Subsequently on revision of ISO 5840:2005 into three parts, the committee also decided to revise IS/ISO 5840:2005 in three parts. This standard has been brought out it in alignment with International Standard. After publication of this standard, IS/ISO 5840:2005 shall be treated as withdrawn. This Indian Standard is published in three parts. The other parts in this series are: Part 1 General requirements Part 2 Surgically implanted heart valve substitutes The text of the ISO Standard has been approved as suitable for publication as an 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 appears referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standard, 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 respective places are listed below along with their degree of equivalence for the editions indicated:
International Standards Corresponding Indian Standards Degree of Equivalence ISO 11135 1, Sterilization of health care products Ethylene MHD 12(489) IS/ISO 11135 : 2014 Sterilization of health care 11135-1:2014 oxide Part 1: Requirements for products-ethylene oxide- Requirements for the development, validation and development, validation and routine control of a routine control of a sterilization process for medical devices sterilization process for medical devices (Under Preparation) ISO 11137 1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137 2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose ISO 11607 1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14971, Medical devices Application of risk management to medical devices ISO 10993 1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993 2, Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 11607-2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes ISO 22442 1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management MHD 12 (494) IS/ISO 11137-1 : 2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Under Preparation) MHD 12 (495) IS/ISO 11137-2 : 2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose (Under Preparation) IS/ISO 11607-1 : 2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems MHD 19(291) IS/ISO 14155:2011 to IS Clinical investigation of medical devices for human subjects Good clinical practice (Under Preparation) IS/ISO 14971:2007 Medical Devices- Application of Risk management to medical devices IS/ISO 10993 1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process MHD 19(271) IS/ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements (Under Preparation) IS/ISO 11607-2 : 2006 Packaging for terminally sterilized medical devices Part 2 Validation Requirements for Forming, Sealing and Assembly Processes MHD 19(12943) IS/ISO 22442 1:2015, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management (Under Preparation) 11137-1:2006 11137-2:2013 11607-1 : 2006 14155:2011 14971:2007 10993-1:2009 Identical 10993-2:2006 with 11607-2:2006 22442-1:2015
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling MHD 19(12944) IS/ISO 22442-2:2015, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling (Under Preparation) 22442-2:2015 The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards/Other Publications and has decided that they are acceptable for use in conjunction with this standard. International Standard ISO/TS 11135 2 ISO 11137 3 ISO 14937 ISO 17665 1 ISO 22442 3 ISO/IEC 17025 IEC 62366 ASTM F2052 ASTM F2503 ASTM F2213 ASTM F2182 ASTM F2119 ISO 14160 ISO 14630:2012 Title Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents General requirements for the competence of testing and calibration laboratories Medical devices Application of usability engineering to medical devices Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment Standard practice for marking medical devices and other items for safety in the magnetic resonance environment Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging Standard test method for evaluation of MR image artifacts from passive implant Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices Non-active surgical implants General requirements The standard also makes a reference to the BIS Certification Marking of the product. Details of which are given in National Annex A. 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. NATIONAL ANNEX A (National Foreword) A-1 BIS CERTIFICATION MARKING The product may also be marked with the Standard Mark. A-1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act, 2016 and the rules and regulations made there under. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. Note: The technical content of the draft is not available on website. For details, please contact: Head (MHD) Bureau of Indian Standards Manak Bhawan 9 Bahadur Shah Zafar Marg New Delhi 110002 Email: mhd@bis.org.in ; hmhd@bis.org.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 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 06 (13463)/IS/ISO 5840-3:2013 TITLE: Draft Indian Standard on Cardiovascular implants Cardiac valve prostheses-part 3: Heart valve substitutes implanted by trans-catheter techniques LAST DATE OF COMMENTS: 03.02.2019 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)