1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 5840-3:2013Cardiovascular implants Cardiac valve prosthesesPart 3: Heart valve substitutes implanted by transcatheter techniques BS EN ISO 5840-3:2013 BRITISH STANDARDN
2、ational forewordThis British Standard is the UK implementation of EN ISO 5840-3:2013.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 5 0 / 2 , C a r d i o v a s c u l a r i m p l a n t s .A list of organizations represented on this committee can b
3、e obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013.ISBN 978 0 580 71177 0 ICS 11.040.40 Comp
4、liance with a British Standard cannot confer immunityfrom legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPIS
5、CHE NORM EN ISO 5840-3 March 2013 ICS 11.040.40 English Version Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) Implants cardiovasculaires - Prothses valvulaires - Partie 3: Valves cardiaques de substitution
6、 implantes par des techniques transcathter (ISO 5840-3:2013) Herz- und Gefimplantate - Herzklappenprothesen - Teil 3: Durch minimal-invasive Methoden implantierter Herzklappenersatz (ISO 5840-3:2013) This European Standard was approved by CEN on 21 January 2013. CEN members are bound to comply with
7、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 national standards may be obtained on application to the CEN-CENELEC Managem
8、ent 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 language and notified to the CEN-CENELEC Management Centre has the same statu
9、s 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
10、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of
11、 exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5840-3:2013: EBS EN ISO 5840-3:2013 EN ISO 5840-3:2013 (E) 3 Foreword This document (EN ISO 5840-3:2013) has been prepared by Technical Committee ISO/TC 150 “Implants forsurgery“ in collaboration
12、with Technical Committee CEN/TC 285 “Non-active surgical implants” thesecretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by September 2013, and conflicting national s
13、tandards shall bewithdrawn at the latest by September 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prep
14、ared under a mandate given to CEN by the European Commission and theEuropean 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 Inter
15、nal Regulations, the national standards organizations of the followingcountries 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, Irela
16、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the UnitedKingdom. Endorsement notice The text of ISO 5840-3:2013 has been approved by CEN as EN ISO 5840-3:2013 without any modification. BS EN
17、ISO 5840-3:2013EN ISO 5840-3:2013 (E) 4 Annex ZA(informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commissionand the European Free Trade Association to
18、 provide one means of conforming to Essential Requirements ofthe New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has beenimplemented as a national standard in at least one Member State, compliance w
19、ith the clauses of thisstandard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption ofconformity with the corresponding Essential Requirements of that Directive and associated EFTAregulations. Table ZA.1 Correspondence between this European Standard and Direct
20、ive 93/42/EECClause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs)of Directive 93/42/EEC Qualifying remarks/Notes Annex C 7.2 7.2.2, 7.2.3 and 7.2.10 7.3 7.2.2.2 8.2 6.2.2.3 d), 6.4 and Annex C 8.3 6.2.4 and Annex E 8.4 6.4 8.5 6.2.2.3 c) and 7.2.5.2 9.2, 3rd indent 6.2.2.1
21、e) and 7.2.4 9.2, 4th indent D.1.3 13.1 For labelling requirements consider also ISO 14630:, 11.2. D.1.2 b) 13.3 a) D.1.1 d), D.1.2 e) and f ) 13.3 b)D.1.1 e) and D.1.2 g) 13.3 c)D.1.1 c) and D.1.2 d) 13.3 d)D.1.1 f ) and D.1.2 h) 13.3 e)D.1.1 g) and D.1.2 i) 13.3 f ) D.1.2 j) 13.3 h) D.1.2 k) 13.3
22、i) D.1.2 l) 13.3 k) D.1.1 e) and D.1.2 g) 13.3 m)D.1.3 a), b), d), i), k), l) and m) 13.6 a) BS EN ISO 5840-3:2013 EN ISO 5840-3:2013 (E) 5 Table (continued) Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs)of Directive 93/42/EEC Qualifying remarks/Notes D.1.3 e) and u)
23、13.6 b) D.1.3 g) 13.6 c) D.1.3 p) 13.6 f ) D.1.3 n) 13.6 g) D.1.3 r) 13.6 i) D.1.3 p) 13.6 n) D.1.3 c) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 5840-3:2013ISO 5840-3:2013(E) ISO 2013 All rights
24、 reserved iiiContents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviations105 Fundamental requirements .106 Device description .106.1 Intended use . 106.2 Design inputs . 106.3 Design outputs . 136.4 Design transfer (manufacturing verification/va
25、lidation) .136.5 Risk management 147 Design verification testing and analysis/design validation .147.1 General requirements 147.2 In vitro assessment . 147.3 Preclinical in vivo evaluation 237.4 Clinical investigations 26Annex A (informative) Rationale for the provisions of this part of ISO 5840 .31
26、Annex B (informative) Examples of transcatheter heart valve substitutes, components and delivery systems .34Annex C (normative) Packaging .40Annex D (normative) Product labels, instructions for use and training 41Annex E (normative) Sterilization .44Annex F (informative) Valve description .45Annex G
27、 (informative) Transcatheter heart valve substitute hazards, associated failure modes and evaluation methods 47Annex H (informative) In vitro test guidelines for paediatric devices 51Annex I (informative) Statistical procedures when using performance criteria 55Annex J (informative) Examples and def
28、initions of some physical and material properties of transcatheter heart valve substitutes and their components 56Annex K (informative) Examples of standards applicable to testing of materials and components of transcatheter heart valve substitutes .69Annex L (informative) Raw and post-conditioning
29、mechanical properties for support structure materials .75Annex M (informative) Corrosion assessment 77Annex N (informative) Guidelines for verification of hydrodynamic performance80Annex O (informative) Durability testing .84Annex P (informative) Fatigue assessment .86Annex Q (informative) Preclinic
30、al in vivo evaluation .92Annex R (normative) Adverse event classification during clinical investigation .95Annex S (informative) Echocardiographic protocol 100BS EN ISO 5840-3:2013ISO 5840-3:2013(E)iv ISO 2013 All rights reservedBibliography . 103BS EN ISO 5840-3:2013ISO 5840-3:2013(E)ForewordISO (t
31、he 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 commit
32、tee 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 electrotech
33、nical 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. Draft International Standards adopted by the technical committees are circulated to the member b
34、odies 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying an
35、y or all such patent rights.ISO 5840-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.ISO 5840 consists of the following parts, under the general title Cardiovascular implants Cardiac valve prostheses: Part
36、3: Heart valve substitutes implanted by minimally invasive techniques ISO 2013 All rights reserved vBS EN ISO 5840-3:2013ISO 5840-3:2013(E)IntroductionNo heart valve substitute is ideal. Therefore, a group of engineers, scientists and clinicians well aware of the problems associated with heart valve
37、 substitutes and their development has prepared this part of ISO 5840. In several areas, the provisions of this part of ISO 5840 have been deliberately left partially defined so as not to inhibit development and innovation. This part of ISO 5840 specifies types of tests, test methods and requirement
38、s for test apparatus. It requires documentation of test methods and results. This part of ISO 5840 deals with those areas that will ensure adequate mitigation of device-associated risks for patients and other users of the device, facilitate quality assurance, aid the cardiac surgeon and cardiologist
39、 in choosing a heart valve substitute, and ensure that the device will be presented in a convenient form. This part of ISO 5840 emphasizes the need to specify types of in vitro testing, preclinical in vivo and clinical evaluations as well as to report all in vitro, preclinical in vivo and clinical e
40、valuations. It describes the labels and packaging of the device. Such a process involving in vitro, preclinical in vivo and clinical evaluations is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent problems.With r
41、egard to in vitro testing and reporting, apart from basic material testing for mechanical, physical, chemical and biocompatibility characteristics, this part of ISO 5840 also covers important hydrodynamic and durability characteristics of transcatheter heart valve substitutes and their delivery syst
42、ems. This part of ISO 5840 does not specify exact test methods for hydrodynamic and durability testing but it offers guidelines for the test apparatus.This part of ISO 5840 should be revised, updated and amended as knowledge and techniques in heart valve substitute technology improve.This part of IS
43、O 5840 is to be used in conjunction with ISO 5840:2005, which will be replaced by ISO 5840-1 in future.vi ISO 2013 All rights reservedBS EN ISO 5840-3:2013Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques1 ScopeThis part of ISO 584
44、0 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the p
45、hysical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.This part of ISO 5840 defines operational condi
46、tions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.This p
47、art of ISO 5840 is applicable to both newly developed and modified transcatheter 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 to be implanted.This part of ISO 5840 excl
48、udes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.This part of ISO 5840 excludes valve-in-valve configurations and homografts.This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutur
49、eless). For these devices, the requirements of both this part of ISO 5840 and ISO 5840:2005 might be relevant and can be considered.NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological evaluation of medical devices Part 1: Evalu
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