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1、BRITISH STANDARD BS EN ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses The European Standard EN ISO 5840:2005 has the status of a British Standard ICS 11.040.40 ? Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolle
2、d Copy, (c) BSI BS EN ISO 5840:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 December 2006 BSI 2006 ISBN 0 580 49872 7 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 5840:2005. It
3、 supersedes BS 6444-1:1990 and BS EN 12006-1:1999, which are withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants. A list of organizations represented on CH/150/2 can be obtained on req
4、uest to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateCommen
5、ts Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840 December 2005 ICS 11.040.40Supersedes EN 12006-1:1999 English Version Cardiovascular implants - C
6、ardiac valve prostheses (ISO 5840:2005) Implants cardiovasculaires - Prothses valvulaires (ISO 5840:2005) Herz- und Gefimplantate - Herzklappenprothesen (ISO 5840:2005) This European Standard was approved by CEN on 28 February 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regul
7、ations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This Eu
8、ropean Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the na
9、tional standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. E
10、UROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5840:2005: E License
11、d Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of ISO 5840:2005 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ of the International Organization for Standardization (ISO)
12、 and has been taken over as EN ISO 5840:2005 by Technical Committee CEN/TC 285 “Non-active surgical implants“, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest
13、 by June 2006, and conflicting national standards shall be withdrawn at the latest by June 2006. This document supersedes EN 12006-1:1999. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requireme
14、nts of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austr
15、ia, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of IS
16、O 5840:2005 has been approved by CEN as EN ISO 5840:2005 without any modifications. EN ISO 5840:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 5840:2005(E) INTERNATIONAL STANDARD ISO
17、5840 Fourth edition 2005-03-01 Cardiovascular implants Cardiac valve prostheses Implants cardiovasculaires Prothses valvulaires EN ISO 5840:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy:
18、 London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword.v Introduction .vi 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Abbreviations 10 5 Fundamental requirements11 6 Device description
19、11 6.1 Intended use11 6.2 Design inputs 11 6.2.1 Operational specifications.11 6.2.2 Performance specifications.12 6.2.3 Packaging, labelling, and sterilization13 6.3 Design outputs13 6.3.1 General.13 6.3.2 Examples of components of some heart valve substitutes .13 6.4 Design transfer (manufacturing
20、 qualification).14 6.5 Risk management .14 6.5.1 Hazard identification.14 6.5.2 Failure mode identification 14 6.5.3 Risk estimation15 6.5.4 Risk evaluation15 6.5.5 Risk control .15 6.5.6 Risk review 15 7 Verification testing and analysis/Design validation15 7.1 General requirements.15 7.2 In vitro
21、assessment.16 7.2.1 Test conditions, sample selection and reporting requirements16 7.2.2 Material property assessment .16 7.2.3 Hydrodynamic performance assessment.17 7.2.4 Structural performance assessment.18 7.3 Preclinical in vivo evaluation.19 7.3.1 Overall requirements19 7.3.2 Methods20 7.3.3 T
22、est report20 7.4 Clinical investigation21 7.4.1 Principle.21 7.4.2 General.21 7.4.3 Number of institutions21 7.4.4 Number of patients .21 7.4.5 Duration of the study22 7.4.6 Clinical data requirements.22 7.4.7 Clinical investigation report.24 Annex A (informative) Rationale for the provisions of thi
23、s International Standard 26 Annex B (informative) Heart valve substitute hazards, associated failure modes and evaluation methods 29 Annex C (informative) Risk assessment guidelines .31 EN ISO 5840:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GM
24、T+00:00 2006, Uncontrolled Copy, (c) BSI iv Annex D (informative) Examples and definitions of some physical and material properties of heart valve substitutes and their components 38 Annex E (informative) Statistical procedures when using performance criteria .43 Annex F (informative) In vitro proce
25、dures for testing unstented or similar valves in compliant chambers .44 Annex G (informative) Preclinical in vivo tests46 Annex H (informative) Echocardiographic protocol49 Annex I (informative) Description of the heart valve substitute.52 Annex J (informative) Figures of examples of components of s
26、ome heart valve substitutes .54 Annex K (informative) Examples of standards applicable to testing of materials and components of some heart valve substitutes.57 Annex L (informative) Guidelines for verification of hydrodynamic performance 63 Annex M (informative) Durability testing69 Annex N (inform
27、ative) Examples of design specific testing.71 Annex O (informative) Fatigue assessment.73 Annex P (normative) Packaging77 Annex Q (normative) Labelling and instructions for use .78 Annex R (normative) Methods of evaluating clinical data80 Annex S (normative) Sterilization .82 Bibliography83 EN ISO 5
28、840:2005 Annex ZA (informative) Relationship between this international Standard and the Essential Requirements of EU Directive 93/4285 Relationship between this International Standard and the Essential Requirements of EU Directive 93/42 Licensed Copy: London South Bank University, London South Bank
29、 University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through IS
30、O technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates c
31、losely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. D
32、raft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this do
33、cument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 5840 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. This fourth edition cance
34、ls and replaces the third edition (ISO 5840:1996), which has been technically revised to include risk management. EN ISO 5840:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vi Introduction There is, as ye
35、t, no heart valve substitute that can be regarded as ideal. This International Standard has been prepared by a group well aware of the problems associated with heart valve substitutes and their development. In several areas, the provisions of this International Standard have been deliberately left o
36、pen as there has been no wish to inhibit development and innovation. It does specify types of tests, test methods and/or requirements for test apparatus, and requires documentation of test methods and results. The areas with which this International Standard is concerned are those which will ensure
37、that associated risks to the patient and other users of the device have been adequately mitigated, facilitate quality assurance, aid the surgeon in choosing a heart valve substitute, and ensure that the device will be presented at the operating table in a convenient form. Emphasis has been placed on
38、 specifying types of in vitro testing, on preclinical in vivo and clinical evaluations, on reporting of all in vitro, preclinical in vivo and clinical evaluations and on the labelling and packaging of the device. Such a process involving in vitro, preclinical in vivo and clinical evaluations is inte
39、nded to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent problems. With regard to in vitro testing and reporting, apart from basic material testing for mechanical, physical, chemical and biocompatibility characteristics, thi
40、s International Standard also covers important hydrodynamic and durability characteristics of heart valve substitutes. The exact test methods for hydrodynamic and durability testing have not been specified, but guidelines for the test apparatus are given. This International Standard is incomplete in
41、 several areas. It is intended to be revised, updated, and/or amended, as knowledge and techniques in heart valve substitute technology improve. Annexes A to S provide supplementary information, the content of Annexes P to S being necessary for the application of this International Standard. EN ISO
42、5840:2005 Licensed Copy: London South Bank University, London South Bank University, Sat Dec 30 06:05:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Cardiovascular implants Cardiac valve prostheses 1 Scope 1.1 This International Standard is applicable to all devices intended for implantation in hum
43、an hearts, as a heart valve substitute. 1.2 This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute
44、to be implanted. 1.3 This International Standard outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to asses
45、s the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. 1.4 This International Standard impose
46、s design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. 1.5 This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assis
47、t devices. NOTE A rationale for the provisions of this International Standard is given in Annex A. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the lates
48、t edition of the referenced document (including any amendments) applies. ISO 8601:2000, Data elements and interchange formats Information interchange Representation of dates and times ISO 10993-1:1997, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-2:1992, Biologic
49、al evaluation of medical devices Part 2: Animal welfare requirements ISO 11134:1994, Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization ISO 11137:1995, Sterilization of health care products Requirements for validation and routine control Radiation sterilization ISO 11607:2003, Packaging for terminally sterilized medic