1、May 2016 English price group 24No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!%SMS“2484248www.din.deDIN
2、EN ISO 5840-2Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015);English version EN ISO 5840-2:2015,English translation of DIN EN ISO 5840-2:2016-05Herz- und Gefimplantate Herzklappenprothesen Teil 2: Chirurgisch implantierter Herzk
3、lappenersatz (ISO 5840-2:2015);Englische Fassung EN ISO 5840-2:2015,Englische bersetzung von DIN EN ISO 5840-2:2016-05Implants cardiovasculaires Prothses valvulaires Partie 2: Prothse valvulaires implantes chirurgicalement (ISO 5840-2:2015);Version anglaise EN ISO 5840-2:2015,Traduction anglaise de
4、DIN EN ISO 5840-2:2016-05SupersedesDIN EN ISO 5840-2:2015-12www.beuth.deDocument comprises 65 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 5840-2:2016-05 2 A comma is used as the decimal marker. Start of app
5、lication The start of application of this standard is 2015-12-01. For DIN EN ISO 5840:2009-08 there is a transition period ending on 2018-09-30. National foreword This document (EN ISO 5840-2:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 2 “Cardiov
6、ascular implants and extracorporeal systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards
7、 Committee Optics and Precision Mechanics), Working Committee NA 027-02-17-01 UA Herz- und Gefimplantate. The DIN Standards corresponding to the European and International Standards referred to in this document are as follows: ISO 5840-1:2015 DIN EN ISO 5840-1:2015 ISO 10993-1 DIN EN ISO 10993-1 ISO
8、 10993-2 DIN EN ISO 10993-2 ISO 14155:2011 DIN EN ISO 14155 ISO 14630:2012 DIN EN ISO 14630 ISO 14971 DIN EN ISO 14971 ISO 16061 DIN EN ISO 16061 ISO/IEC 17025:2005 DIN EN ISO/IEC 17025:2005 ISO 22442 (all parts) DIN EN ISO 22442 (all parts) Amendments This standard differs from DIN EN ISO 5840:2009
9、-08 as follows: a) the standard has been subdivided into three parts dealing with “general requirements”, “surgically implanted heart valve substitutes” and “heart valve substitutes implanted by transcatheter techniques”; b) the content has been updated and brought into line with Part 3 of the stand
10、ard, which has already been published; c) the standard has been editorially revised. Compared with DIN EN ISO 5840-2:2015-12, the following correction has been made to the revision: the transition period in the “Start of application” has been corrected. Previous editions DIN EN 12006-1: 1999-10 DIN
11、EN ISO 5840: 2006-03, 2009-08 DIN EN ISO 5840-2: 2015-12 a) DIN EN ISO 5840-2:2016-05 3 National Annex NA (informative) Bibliography 1 DIN EN ISO 5840-1:2015, Cardiovascular implants Cardiac valve prostheses Part 1: General requirements 2 DIN EN ISO 10993-1, Biological evaluation of medical devices
12、Part 1: Evaluation and testing within a risk management system 3 DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements 4 DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice 5 DIN EN ISO 14630, Non-active sur
13、gical implants General requirements 6 DIN EN ISO 14971, Medical devices Application of risk management to medical devices 7 DIN EN ISO 16061, Instrumentation for use in association with non-active surgical implants General requirements 8 DIN EN ISO/IEC 17025, General requirements for the competence
14、of testing and calibration laboratories 9 DIN EN ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives DIN EN ISO 5840-2:2016-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840-2 September 2015 ICS 11.040.40 Supersedes
15、EN ISO 5840:2009English Version 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 Gefimplan
16、tate - Herzklappenprothesen - 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 t
17、he 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, Fre
18、nch, 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria
19、, Croatia, Cyprus, Czech Republic, 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
20、 and United Kingdom. EUROPEAN 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
21、. No. EN ISO 5840-2:2015 EEuropean foreword .4Introduction . 61 Scope . 72 Normative references 73 Terms and definitions . 84 Abbreviations 105 Fundamental requirements . 106 Device description . 116.1 Intended use . 116.2 Design inputs . 116.2.1 Operational specifications 116.2.2 Performance specif
22、ications . 116.2.3 Packaging, labelling, and sterilization 126.3 Design outputs . 126.3.1 General. 126.4 Design transfer (manufacturing qualification) 126.5 Risk management 127 Design verification testing and analysis/design validation . 127.1 General requirements 127.2 In vitro assessment . 137.2.1
23、 Test conditions, sample selection, and reporting requirements . 137.2.2 Material property assessment 147.2.3 Hydrodynamic performance assessment 147.2.4 Structural performance assessment 167.2.5 Device MRI safety .177.2.6 Additional implant design evaluation requirements .177.2.7 Design specific te
24、sting 187.2.8 Simulated use.187.2.9 Human factors/usability assessment .187.3 Preclinical in vivo evaluation 187.3.1 Overall requirements 187.3.2 Methods 197.3.3 Test report 207.4 Clinical investigation . 217.4.1 General. 217.4.2 Statistical considerations 217.4.3 Distribution of subjects and invest
25、igators 217.4.4 Sample size 217.4.5 Entry criteria 227.4.6 Duration of the study 227.4.7 Clinical data requirements . 227.4.8 Clinical investigation report 24Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods 26Annex B (informative) In vitro proced
26、ures for testing unstented or similar valves in compliant chambers 29Annex C (informative) Preclinical in vivo evaluation .31Contents PageDIN EN ISO 5840-2:2016-05 EN ISO 5840-2:2015 (E) 2Foreword . 5Annex F (informative) Guidelines for verification of hydrodynamic performance 40Annex G (informative
27、) Durability testing .49Annex H (informative) Examples of design specific testing .51Annex I (informative) Fatigue assessment 53Annex J (normative) Methods of evaluating clinical data 59Bibliography .61Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
28、of EU Directive 93/42/EEC on medical devices 6 0 DIN EN ISO 5840-2:2016-05 EN ISO 5840-2:2015 (E) 3Annex D (informative) Description of the surgical heart valve substitute.34Annex E (informative) Examples of components of some surgical heart valve substitutes .36.European foreword This document (EN
29、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. This European Standard shall be given the status of a national standard, either by
30、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 the elements of this document may be the subject of patent rights. CEN and/or CEN
31、ELEC 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 European Free Trade Association, and supports essential requirements of EU Dire
32、ctive(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: Austria, Belgium, B
33、ulgaria, Croatia, Cyprus, Czech Republic, 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,
34、 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. DIN EN ISO 5840-2:2016-05 EN ISO 5840-2:2015 (E) 4 ForewordISO (the International Organization for Standardization) is a worldwide federation of nat
35、ional standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO 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. Interna
36、tional organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intend
37、ed for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types 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.i
38、so.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 held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document wil
39、l 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 given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressi
40、ons related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC
41、 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 5840:2005, which has been technically revised.ISO 5840 consists of the following parts, under the general title Cardiovascular implants Cardiac v
42、alve prostheses: Part 1: General requirements Part 2: Surgically implanted heart valve substitutes Part 3: Heart valve substitutes implanted by transcatheter techniquesDIN EN ISO 5840-2:2016-05 EN ISO 5840-2:2015 (E) 5 IntroductionThis part of ISO 5840 has been prepared for surgical heart valve subs
43、titutes with emphasis on specifying types of in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, preclinical in vivo, and clinical evaluations and labelling and packaging of the device. This process is intended to clarify the required procedures prior to market
44、 release and to enable prompt identification and management of any subsequent issues.This part of ISO 5840 is to be used in conjunction with ISO 5840-1.DIN EN ISO 5840-2:2016-05 EN ISO 5840-2:2015 (E) 6 1 ScopeThis part of ISO 5840 is applicable to heart valve substitutes intended for implantation i
45、n human hearts, generally requiring 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 determ
46、ining the appropriate size of the surgical 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 derive
47、d from the risk assessment. The tests 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 t
48、he finished surgical heart valve substitute.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 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 584
