1、BSI Standards PublicationBS EN ISO 5840-2:2015Cardiovascular implants Cardiac valve prosthesesPart 2: Surgically implanted heart valve substitutesBS EN ISO 5840-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5840-2:2015. It supersedes BS EN ISO 5840:
2、2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary prov
3、isions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 82708 2 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publ
4、ished under the authority of the Standards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840-2 September 2015 ICS 11.040.40 Supersedes EN ISO 5840:2009English Versio
5、n Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) Implants cardiovasculaires - Prothses valvulaires - Partie 2: Prothse valvulaires implantes chirurgicalement (ISO 5840-2:2015) Herz- und Gefimplantate - Herzklappenprothesen
6、- Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015) This European Standard was approved by CEN on 24 July 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stan
7、dard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in a
8、ny other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep
9、ublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEA
10、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5840-2:2015 EBS
11、 EN ISO 5840-2:2015EN ISO 5840-2:2015 (E) 3 European foreword This document (EN ISO 5840-2:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. Thi
12、s European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by September 2018. Attention is drawn to the possibility that some of t
13、he elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5840:2009. This document has been prepared under a mandate given to CEN by the European Commission and the
14、 European Free Trade Association, and supports essential requirements 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 follow
15、ing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No
16、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5840-2:2015 has been approved by CEN as EN ISO 5840-2:2015 without any modification. BS EN ISO 5840-2:2015EN ISO 5840-2:2015 (E) 4 Annex ZA (informative)
17、 Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essent
18、ial Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given
19、 in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Cl
20、ause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes Clause 5, 6.1, 6.2.1, 6.2.2, 6.4 7.1 6.2, 6.2.3, 6.4, 7.2.2.2 7.2 6.2, 6.4 7.3 6.2, 6.4, 6.5, 7.2.2.2 7.5 6.2.2, 6.4, 6.5 7.6 6.2, 6.4, 6.5 8.1 6.5, 7.2.2.2 8.2 6.2.3 8.3 6.2.
21、3 8.4 6.4 8.5 6.2.3 8.6 6.2.3 8.7 6.3, 6.2.3 9.1 6.2.1, 6.2.2, 6.4, 6.5 9.2 6.2.3, 6.3 13 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 5840-2:2015ISO 5840-2:2015(E)Foreword vIntroduction vi1 Scope . 12 Nor
22、mative references 13 Terms and definitions . 24 Abbreviations. 45 Fundamental requirements 46 Device description 56.1 Intended use 56.2 Design inputs 56.2.1 Operational specifications . 56.2.2 Performance specifications 56.2.3 Packaging, labelling, and sterilization . 66.3 Design outputs 66.3.1 Gene
23、ral 66.4 Design transfer (manufacturing qualification) . 66.5 Risk management . 67 Design verification testing and analysis/design validation 67.1 General requirements . 67.2 In vitro assessment 77.2.1 Test conditions, sample selection, and reporting requirements 77.2.2 Material property assessment
24、. 87.2.3 Hydrodynamic performance assessment . 87.2.4 Structural performance assessment 107.2.5 Device MRI safety .117.2.6 Additional implant design evaluation requirements .117.2.7 Design specific testing 127.2.8 Simulated use.127.2.9 Human factors/usability assessment .127.3 Preclinical in vivo ev
25、aluation 127.3.1 Overall requirements 127.3.2 Methods 137.3.3 Test report 147.4 Clinical investigation . 157.4.1 General. 157.4.2 Statistical considerations 157.4.3 Distribution of subjects and investigators 157.4.4 Sample size 157.4.5 Entry criteria 167.4.6 Duration of the study 167.4.7 Clinical da
26、ta requirements . 167.4.8 Clinical investigation report 18Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods 20Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers 23Annex C (informative) Preclinic
27、al in vivo evaluation .25Annex D (informative) Description of the surgical heart valve substitute.28Annex E (informative) Examples of components of some surgical heart valve substitutes .30 ISO 2015 All rights reserved iiiContents PageBS EN ISO 5840-2:2015ISO 5840-2:2015(E)Annex F (informative) Guid
28、elines for verification of hydrodynamic performance 34Annex G (informative) Durability testing .43Annex H (informative) Examples of design specific testing .45Annex I (informative) Fatigue assessment 47Annex J (normative) Methods of evaluating clinical data 53Bibliography .54iv ISO 2015 All rights r
29、eservedBS EN ISO 5840-2:2015ISO 5840-2:2015(E)ForewordISO (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 ISO technical committees. Each memb
30、er 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 closely with the International Ele
31、ctrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types
32、of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be hel
33、d responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information
34、 given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the foll
35、owing URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This first edition of ISO 5840-2, together with ISO 5840-1 and ISO 5840-3, cancels and replaces ISO 58
36、40:2005, which has been technically revised.ISO 5840 consists of the following parts, under the general title Cardiovascular implants Cardiac valve prostheses: Part 1: General requirements Part 2: Surgically implanted heart valve substitutes Part 3: Heart valve substitutes implanted by transcatheter
37、 techniques ISO 2015 All rights reserved vBS EN ISO 5840-2:2015ISO 5840-2:2015(E)IntroductionThis part of ISO 5840 has been prepared for surgical heart valve substitutes with emphasis on specifying types of in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, pr
38、eclinical in vivo, and clinical evaluations and labelling and packaging of the device. This process is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent issues.This part of ISO 5840 is to be used in conjunction wi
39、th ISO 5840-1.vi ISO 2015 All rights reservedBS EN ISO 5840-2:2015Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes1 ScopeThis part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring
40、cardiopulmonary bypass and generally with direct visualization.This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the su
41、rgical heart valve substitute to be implanted.This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The test
42、s may include those to assess the physical, chemical, biological, and mechanical properties of surgical 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 surgical heart valve sub
43、stitute.This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and
44、ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.This part of ISO 5840
45、excludes homografts.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (
46、including any amendments) applies.ISO 5840-1:2015, Cardiovascular implants and extracorporeal systems Cardiac valve prostheses Part 1: General requirementsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-2, Biological eval
47、uation of medical devices Part 2: Animal welfare requirementsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14630, Non-active surgical implants General requirementsISO 14971, Medical devices Application of risk management to medical devicesISO 16061
48、, Instrumentation for use in association with non-active surgical implants General requirementsINTERNATIONAL STANDARD ISO 5840-2:2015(E) ISO 2015 All rights reserved 1BS EN ISO 5840-2:2015ISO 5840-2:2015(E)ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laborat
49、oriesISO 22442 (all parts), Medical devices utilizing animal tissues and their derivativesASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive ImplantsASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance ImagingASTM F2213, Standard Test Method for Measuremen
