BS EN ISO 10993-4-2017 Biological evaluation of medical devices Selection of tests for interactions with blood《医疗器械的生物评估 与血液相互作用的试验选择》.pdf

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1、Biological evaluation of medical devicesPart 4: Selection of tests for interactions with bloodBS EN ISO 109934:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 109934:2017. It supersedes BS

2、EN ISO 109934:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to

3、include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 84457 7ICS 11.100.20Compliance with a British Standard cannot confer immunity from legal obligations. Th

4、is British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 109934:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 109934May 2017ICS 11.100.20 S

5、upersedes EN ISO 109934:2009EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2017 CEN Ref. No. EN ISO 109934:2017: EAll rights of exploitation in any form and by any means reserved worldwi

6、de for CEN national MembersBiological evaluation of medical devices Part 4: Selection of tests for interactions with blood (ISO 109934:2017) valuation biologique des dispositifs mdicaux Partie 4: Choix des essais pour les interactions avec le sang (ISO 109934:2017) Biologische Beurteilung von Medizi

7、nprodukten Teil 4: Auswahl von Prfungen zur Wechselwirkung mit Blut (ISO 109934:2017) This European Standard was approved by CEN on 23 February 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status o

8、f a national standard without any alteration. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the CENCENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A

9、 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, Croatia, Cypru

10、s, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and Uni

11、ted Kingdom.English VersionEN ISO 109934:2017 (E)European forewordThis document (EN ISO 109934:2017) has been prepared by Technical Committee ISO/TC 194 “Biological and clinical evaluation of medical devices” in collaboration with Technical Committee CEN/TC 206 “Biological and clinical evaluation of

12、 medical devices” 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 November 2017, and conflicting national standards shall be withdrawn at the latest by Nove

13、mber 2017.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 supersedes EN ISO 109934:2009.This document has been prepared u

14、nder a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA and Annex ZB, which is an integral part of this document.According to the CENCENELEC

15、Internal Regulations, the national standards organizations 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, Icelan

16、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 109934:2017 has been approved by CEN as EN ISO 109934:2017 without any modi

17、fication.iiBS EN ISO 109934:2017EN ISO 109934:2017 (E)Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be coveredThis European Standard has been prepared under a Commissions joint standardization request M/BC/C

18、EN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169.Once this standard is cited in the Official

19、 Journal of the European Union under that Directive, compliance with the normative clauses of this standard given 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 re

20、gulations.NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest

21、possible level, minimized or removed, according to the wording of the corresponding essential requirement.NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.NOTE 3 This Annex ZA is based on

22、 normative references according to the table of references in the European foreword, replacing the references in the core text.NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.Table ZA.1 Correspondence between this Europe

23、an Standard and Annex I of Directive 93/42/EEC OJ L 169Essential Requirements of Directive 93/42/EECClause(s)/subclause(s) of this ENRemarks/Notes7.1 (First indent)6.1 and A.1, B.1, C.1, D.1 and E.1ER 7.1 (first indent) is partly covered by ISO 109934, since the standard does not provide requirement

24、s on design and manufacture. However, this standard provides a means to evaluate the interactions of medical devices with blood. Other forms of toxicity and flammability are not dealt with in this standard.7.1 (Second indent)6.1 and A.1, B.1, C.1, D.1 and E.1ER 7.1 (second indent) is partly covered

25、by ISO 109934, since the standard does not provide requirements on design and manufacture. However, this standard provides a means to evaluate the interactions of medical devices with blood. Other forms of toxicity are not dealt with in this standard. This evaluation can be a preliminary step for ri

26、sk minimization.3BS EN ISO 109934:2017EN ISO 109934:2017 (E)Essential Requirements of Directive 93/42/EECClause(s)/subclause(s) of this ENRemarks/Notes7.26.1 and A.1, B.1, C.1, D.1 and E.1ER 7.2 is partly covered by ISO 109934, since the standard does not provide requirements on design, manufacture

27、and packaging. However, this standard provides a means to assess the interactions of medical devices with blood to contaminants and residues in medical devices.7.56.1 and A.1, B.1, C.1, D.1 and E.1ER 7.5 is partly covered by ISO 109934, since the standard does not provide requirements on design and

28、manufacture. However, this standard provides a means to evaluate interactions of substances leaking from medical devices with blood.General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of ISO 109931.WARNING 1 Presumption of conformity stays valid onl

29、y as long as a reference to this European Standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.WARNING 2 Other Union legislation may be appl

30、icable to the products falling within the scope of this standard.4BS EN ISO 109934:2017ISO 109934:2017(E)Foreword viIntroduction viii1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviated terms 45 Types of devices in contact with blood (as categorized in ISO 109931) 55.1 Nonbloo

31、dcontact devices . 55.2 External communicating devices 55.2.1 General 55.2.2 External communicating devices that serve as an indirect blood path 55.2.3 External communicating devices directly contacting circulating blood 55.3 Implant devices 66 Characterization of blood interactions . 66.1 General r

32、equirements . 66.2 Categories of tests and blood interactions . 126.2.1 Recommended tests for interactions of devices with blood .126.2.2 Noncontact devices .136.2.3 External communicating devices and implant devices136.2.4 Limitations . 136.3 Types of tests . 136.3.1 In vitro tests . 136.3.2 Ex viv

33、o tests . 146.3.3 In vivo tests 14Annex A (informative) Preclinical evaluation of cardiovascular devices and prostheses .16Annex B (informative) Recommended laboratory tests Principles, scientific basis and interpretation .21Annex C (informative) Thrombosis Methods for in vivo testing 32Annex D (inf

34、ormative) Haematology/haemolysis Methods for testing Evaluation of haemolytic properties of medical devices and medical device materials .39Annex E (informative) Complement Methods for testing .46Annex F (informative) Less common laboratory tests 49Annex G (informative) Tests which are not recommend

35、ed 53Bibliography .55 ISO 2017 All rights reserved vContents PageBS EN ISO 109934:2017ISO 109934:2017(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 normal

36、ly 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 nongovernmental, in liaison with ISO, also take part in the

37、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

38、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

39、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

40、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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information abou

41、t ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices.This third edition cance

42、ls and replaces the second edition (ISO 109934:2002), which has been technically revised.It also incorporates the Amendment ISO 109934:2002/Amd 1:2006.The following changes were made:a) some definitions have been revised and new definitions have been added;b) Tables 1 and 2 have been consolidated in

43、to a single new Table 1 with test categories and headers reorganized to emphasize and include material and mechanicalinduced haemolysis testing and in vitro and in vivo testing for assessment of risk for thrombosis;c) Tables 3 and 4 have been consolidated into a single new Table 2 with a simplified

44、list of suggested and most common tests;d) Annex B has been updated to cover only the most common practiced tests for assessing blood interactions;e) Annex C has been added to cover the topic of in vivo thrombosis and methods for testing;f) Annex D, which was Annex C in the previous edition, has bee

45、n updated and now includes added information on mechanically-induced haemolysis;g) Annex E has been added to cover the topic of complement testing and best test method practices;h) Annexes F and G have been added to present the less common tests used to assess interactions with blood and the tests t

46、hat are not recommended for preclinical assessment of medical device blood interaction, respectively. Many of these methods were previously included in Annex B;vi ISO 2017 All rights reservedBS EN ISO 109934:2017ISO 109934:2017(E)i) subtle language refinements can be found throughout the revised doc

47、ument;j) the Bibliography has been reorganized by common subjects of interest and updated with additional and more current references. ISO 2017 All rights reserved viiBS EN ISO 109934:2017ISO 109934:2017(E)IntroductionThe selection and design of test methods for the interactions of medical devices w

48、ith blood should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.The initial source for developing this document was the publication, Guidelines for blood/material interactions

49、, Report of the National Heart, Lung, and Blood Institute14chapters 9 and 10. This publication was subsequently revised15.viii ISO 2017 All rights reservedBS EN ISO 109934:2017Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood1 ScopeThis document specifies general requirements for evaluating the interactions of medical devices with blood.It describesa) a classification of medical devices that are intended for use in contact w