BS EN ISO 5840-1-2015 Cardiovascular implants Cardiac valve prostheses General requirements《心血管植入物 心脏瓣膜假体 通用要求》.pdf

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1、BSI Standards PublicationBS EN ISO 5840-1:2015Cardiovascular implants Cardiac valve prosthesesPart 1: General requirementsBS EN ISO 5840-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO5840-1:2015.The UK participation in its preparation was entrusted t

2、o TechnicalCommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The Britis

3、h Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 80484 7ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2

4、015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840-1 September 2015 ICS 11.040.40 English Version Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) Implants card

5、iovasculaires - 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 was approved by CEN on 10 July 2015. CEN members are bound to comply with the CEN/CENELEC Int

6、ernal 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 Management Centre or to an

7、y 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 status as the official v

8、ersions. 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, Netherlands, Norwa

9、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited 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 exploit

10、ation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5840-1:2015 EBS EN ISO 5840-1:2015EN ISO 5840-1:2015 (E) 3 European foreword This document (EN ISO 5840-1:2015) has been prepared by Technical Committee ISO/TC 150“Implants for surgery” in collaboration w

11、ith Technical Committee CEN/TC 285 “Non-active surgicalimplants” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national standa

12、rds shallbe withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document has been prepared under

13、 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 thisdocument. According to the CEN-CENELEC Internal Regulat

14、ions, the national standards organizations of thefollowing 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,

15、Latvia, Lithuania, Luxembourg, Malta,Netherlands, 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 anymodification. BS EN ISO 5840-1:20

16、15EN ISO 5840-1:2015 (E) 4 Annex ZA (informative)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 EuropeanCommission and the European Free Trade Associa

17、tion to provide a means of conforming to EssentialRequirements 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 hasbeen implemented as a national standard in at least one Member State, compl

18、iance with the clauses ofthis standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumptionof conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard an

19、d Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s)of this European Standard Essential Requirements (ERs)of Directive 93/42/EEC Qualifying remarks/Notes 5, 6, 7 7.1 5, 6.2.4, 6.4, 6.5 7.2 6.2.2, 6.2.3, 7.3 7.3 6.5 7.5 6.2.2, 6.5 7.6 5, 6.4, 6.5 8.1 6.2.4, 6.4 8.3 6.2.4 8.4 6.4 8.5 6.2.4

20、 8.6 6.2.4 8.7 6.2.1, 6.3, 7 9.1 6.2.1, 6.3, 6.4, 6.5, 7 9.2, 1. indent 6.4, 6.5, 7 9.2, 2. indent 6.4, 6.5, 7 9.2, 3. indent 6.2.1, 6.3, 6.4, 6.5, 7 9.2, 4. indent 6.2.4 13 WARNING Other requirements and other EU Directives may be applicable to the product(s) fallingwithin the scope of this standar

21、d. BS EN ISO 5840-1:2015ISO 5840-1:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviations115 Fundamental requirements .126 Device description .126.1 Intended use . 126.2 Design inputs . 126.2.1 Operational specifications 126.2.2 Performance spec

22、ifications . 126.2.3 Implant procedure.126.2.4 Packaging, labelling, and sterilization 136.3 Design outputs . 136.4 Design transfer (manufacturing verification/validation) .146.5 Risk management 147 Design verification testing and analysis/design validation .157.1 General requirements 157.2 In vitro

23、 assessment . 157.3 Preclinical in vivo evaluation 157.4 Clinical investigations 15Annex A (informative) Rationale for the provisions of this part of ISO 5480 .16Annex B (normative) Packaging .19Annex C (normative) Product labels, instructions for use, and training .20Annex D (normative) Sterilizati

24、on .23Annex E (informative) In vitro test guidelines for paediatric devices 24Annex F (informative) Statistical procedures when using in vitro performance criteria 28Annex G (informative) Examples and definitions of some physical and material properties of heart valve systems 29Annex H (informative)

25、 Examples of standards applicable to testing of materials and components of heart valve systems .40Annex I (informative) Raw and post-conditioning mechanical properties for support structure materials .46Annex J (informative) Corrosion assessment .48Annex K (informative) Echocardiographic protocol .

26、51Bibliography .54 ISO 2015 All rights reserved iiiContents PageBS EN ISO 5840-1:2015ISO 5840-1:2015(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 normall

27、y 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. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the

28、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 intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the di

29、fferent 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.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document

30、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 will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/pat

31、ents).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 expressions related to conformity assessment, as well as information about ISOs adherence to the WTO princip

32、les in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary Information The 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 5840-1, together w

33、ith ISO 5840-2 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 valve prostheses: Part 1: General requirements Part 2: Surgically implanted heart valve substitutes

34、Part 3: Heart valve substitutes implanted by transcatheter techniquesiv ISO 2015 All rights reservedBS EN ISO 5840-1:2015ISO 5840-1:2015(E)IntroductionThere 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 a

35、ssociated with heart valve substitutes and their development. In several areas, the provisions of the ISO 5840series deliberately 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 doc

36、umentation of test methods and results. The areas with which the ISO 5840series are concerned are those which will ensure that associated 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 subst

37、itute, and ensure that the device will be presented at the operating table in convenient form. Emphasis has been placed on 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 la

38、belling 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 regard to in vitro testing a

39、nd reporting, apart from basic material testing for mechanical, physical, chemical, and biocompatibility characteristics, the ISO 5840series also covers important hydrodynamic and durability characteristics of heart valve substitutes. The ISO 5840series does not specify exact test methods for hydrod

40、ynamic and durability testing, but it offers guidelines for the test apparatus.The ISO 5840series is incomplete in several areas. It is intended to be revised, updated, and/or amended as knowledge and techniques in heart valve substitute technology improve. ISO 2015 All rights reserved vBS EN ISO 58

41、40-1:2015BS EN ISO 5840-1:2015Cardiovascular implants Cardiac valve prostheses Part 1: General requirements1 ScopeThis part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840series provide specific

42、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 of the heart valve substitute to be implanted.This part of ISO 5840

43、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 assess the physical, chemical, biological, and mechani

44、cal 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 5840 defines operational conditions for heart valve substitutes.This pa

45、rt 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 th

46、e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 5840-2, Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutesISO 5840-3, Cardiovascular implants Cardiac valve prosthe

47、ses Part 3: Heart valve substitutes implanted by transcatheter techniquesISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 11137 (all parts), Sterilization of health care

48、products RadiationISO 11607 (all parts), Packaging for terminally sterilized medical devicesISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices

49、 utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesISO 14630:2012, Non-active surgical implants General requirementsINTERNATIONAL STANDARD ISO 5840-1:2015(E) ISO 2015 All rights reserved 1BS EN ISO 5840-1:2015ISO 5840-1:2015(E)ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a steriliz