1、December 2015 English price group 25No 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!%Jk“2399672www.din.de
2、DIN EN ISO 5840-1Cardiovascular implants Cardiac valve prostheses Part 1: General requirements (ISO 5840-1:2015);English version EN ISO 5840-1:2015,English translation of DIN EN ISO 5840-1:2015-12Herz- und Gefimplantate Herzklappenprothesen Teil 1: Allgemeine Anforderungen (ISO 5840-1:2015);Englisch
3、e Fassung EN ISO 5840-1:2015,Englische bersetzung von DIN EN ISO 5840-1:2015-12Implants cardiovasculaires Prothses valvulaires Partie 1: Exigences gnrales (ISO 5840-1:2015);Version anglaise EN ISO 5840-1:2015,Traduction anglaise de DIN EN ISO 5840-1:2015-12www.beuth.deDocument comprises 66 pagesDTra
4、nslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.15DIN EN ISO 5840-1:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 5840-1:2015) has been prepared by Technical Committee ISO/TC 150 “Implants f
5、or surgery”, Subcommittee SC 2 “Cardiovascular 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-Normenausschus
6、s Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-17-01 UA Herz- und Gefimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5840-2 DIN EN ISO 5840-2 ISO 5840-3 DIN EN
7、ISO 5840-3 ISO 11135 DIN EN ISO 11135 ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 11607 (all parts) DIN EN ISO 11607 (all parts) ISO 14155 DIN EN ISO 14155 ISO 14160 DIN EN ISO 14160 ISO 14630:2012 DIN EN ISO 14630:2013-03 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17665 (a
8、ll parts) DIN EN ISO 17665 (all parts) DIN EN ISO 5840-1:2015-12 3 National Annex NA (informative) Bibliography 1 DIN EN ISO 5840-2, Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes 2 DIN EN ISO 5840-3, Cardiovascular implants Cardiac valve prosth
9、eses Part 3: Heart valve substitutes implanted by transcatheter techniques 3 DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices 4 DIN EN ISO 11137 (all parts), Steriliz
10、ation of health care products Radiation 5 DIN EN ISO 11607 (all parts), Packaging for terminally sterilized medical devices 6 DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice 7 DIN EN ISO 14160, Sterilization of health care products Liquid chemica
11、l 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 8 DIN EN ISO 14630:2013-03, Non-active surgical implants General requiremen
12、ts (ISO 14630:2012) 9 DIN EN ISO 14937, 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 10 DIN EN ISO 14971, Medical devices Application of risk m
13、anagement to medical devices 11 DIN EN ISO 17665 (all parts), Sterilization of health care products Moist heat DIN EN ISO 5840-1:2015-12 4 Page intentionally left blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840-1 September 2015 ICS 11.040.40 English Version Cardiovascular implant
14、s - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) Implants cardiovasculaires - Prothses valvulaires - Partie 1: Exigences gnrales (ISO 5840-1:2015) Herz- und Gefimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen (ISO 5840-1:2015)This European Standard wa
15、s approved by CEN on 10 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 standard without any alteration. Up-to-date lists and bibliographical references concerning such nati
16、onal 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 any other language made by translation under the responsibility of a CEN member into its own langu
17、age 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
18、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-
19、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 5840-1:2015 EContents Page European foreword. . 3 Foreword 4Introduction 51 Scope . 62 Normative references 63 Te
20、rms and definitions . 74 Abbreviations165 Fundamental requirements .176 Device description .176.1 Intended use . 176.2 Design inputs . 176.2.1 Operational specifications 176.2.2 Performance specifications . 176.2.3 Implant procedure.176.2.4 Packaging, labelling, and sterilization 186.3 Design output
21、s . 186.4 Design transfer (manufacturing verification/validation) .196.5 Risk management 197 Design verification testing and analysis/design validation .207.1 General requirements 207.2 In vitro assessment . 207.3 Preclinical in vivo evaluation 207.4 Clinical investigations 20Annex A (informative) R
22、ationale for the provisions of this part of ISO 5480 21Annex B (normative) Packaging 24Annex C (normative) Product labels, instructions for use, and training 25Annex D (normative) Sterilization 28Annex E (informative) In vitro test guidelines for paediatric devices .29Annex F (informative) Statistic
23、al procedures when using in vitro performance criteria .33Annex G (informative) Examples and definitions of some physical and material properties of heart valve systems 34Annex H (informative) Examples of standards applicable to testing of materials and components of heart valve systems .45Annex I (
24、informative) Raw and post-conditioning mechanical properties for support structure materials .51Annex J (informative) Corrosion assessment 53Annex K (informative) Echocardiographic protocol 56Bibliography .60Annex ZA (informative) Relationship between this European Standard and the Essential Require
25、ments of EU Directive 93/42/EEC on medical devices 59 2 EN ISO 5840-1:2015 (E) DIN EN ISO 5840-1:2015-12European foreword This document (EN ISO 5840-1:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active sur
26、gical implants” the secretariat of which is held by DIN. 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 by March 2016, and conflicting national standards shall be withdrawn at the latest by March 20
27、16. Attention is drawn to the possibility that some of the 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 has been prepared under a mandate given to CEN by the European Commi
28、ssion and the 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
29、of the following 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, Ne
30、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5840-1:2015 has been approved by CEN as EN ISO 5840-1:2015 without any modification. 3EN ISO 5840-1:2015 (E)DIN EN ISO 5840-1:2015-12Forewor
31、dISO (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 member body interested in a subject for which a technical
32、 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 Electrotechnical Commission (IEC) on all matters of elec
33、trotechnical 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 of ISO documents should be noted. This document was d
34、rafted 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 held responsible for identifying any or all such patent
35、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 given for the convenience of users and does not cons
36、titute 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 following URL: Foreword - Supplementary Information The c
37、ommittee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This first edition of ISO 5840-1, together with ISO 5840-2 and ISO 5840-3, cancels and replaces ISO 5840:2005, which has been technically revised.ISO 5840
38、 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 techniques4 EN ISO 5840-1:2015 (E) DIN EN ISO 5840-
39、1:2015-12IntroductionThere is, as yet, no heart valve substitute which can be regarded as ideal.The ISO 5840series has been prepared by a group well aware of the issues associated with heart valve substitutes and their development. In several areas, the provisions of the ISO 5840series deliberately
40、have not been specified to encourage development and innovation. It does specify the types of tests, test methods, and/or requirements for test apparatus and requires documentation of test methods and results. The areas with which the ISO 5840series are concerned are those which will ensure that ass
41、ociated risks to the patient and other users of the device have been adequately mitigated, facilitate quality assurance, aid the clinician in choosing a heart valve substitute, and ensure that the device will be presented at the operating table in convenient form. Emphasis has been placed on specify
42、ing 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 intended
43、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, the ISO
44、5840series also covers important hydrodynamic and durability characteristics of heart valve substitutes. The ISO 5840series does not specify exact test methods for hydrodynamic and durability testing, but it offers guidelines for the test apparatus.The ISO 5840series is incomplete in several areas.
45、It is intended to be revised, updated, and/or amended as knowledge and techniques in heart valve substitute technology improve.5EN ISO 5840-1:2015 (E)DIN EN ISO 5840-1:2015-121 ScopeThis part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general re
46、quirements. Subsequent parts of the ISO 5840series provide specific requirements.This part of ISO 5840 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size
47、of the heart valve substitute to be implanted.This part of ISO 5840 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 inc
48、lude those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.This part of ISO 584
49、0 defines operational conditions for heart valve substitutes.This part of ISO 5840 excludes homografts.NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.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 (including any amendments) applies.IS
