EN ISO 14607-2018 en Non-active surgical implants - Mammary implants - Particular requirements.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Non-active surgical implants Mammary implants Particular requirements (ISO 14607:2018)BS EN ISO 14607:2018National forewordThis British Standard is the UK implementation of EN ISO 14607:2018. It supersedes BS EN ISO 146

2、07:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provi

3、sions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 89051 2ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publishe

4、d under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 14607:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14607May 2018ICS 11.040.40 Supersedes EN ISO 14607:2009EUROPEA

5、N COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 14607:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersNon-act

6、ive surgical implants - Mammary implants - Particular requirements (ISO 14607:2018)Implants chirurgicaux non actifs - Implants mammaires - Exigences particulires (ISO 14607:2018)Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2018)This European Standard was

7、 approved by CEN on 26 February 2018.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 na

8、tional 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 lang

9、uage 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,

10、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 14607:2018 (E)European forewordThis document (EN ISO 14607:2018) has been p

11、repared 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 publication of an identical

12、text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for ide

13、ntifying any or all such patent rights.This document supersedes EN ISO 14607:2009.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 Directive(s).For relationship with EU Directive

14、(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, Bulgaria, Croatia, Cyprus, Czech Republic, Den

15、mark, 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 the United Kingdom.The fo

16、llowing 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.When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference t

17、o the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.Table Correlation between

18、 normative references and dated EN and ISO standardsNormative references as listed in Clause 2 of the ISO standardEquivalent dated standardEN ISO or IECISO 34-1:2015 ISO 34-1:2015ISO 37:2017 ISO 37:2017ISO 4287 EN ISO 4287:1998, EN ISO 4287:1998/AC:2008 and EN ISO 4287:1998/A1:2009ISO 4287:1997, ISO

19、 4287:1997/Cor 1:1998/Cor 2:2005 and ISO 4287:1997/Amd:2009ISO 7619-1 ISO 7619-1:2010ISO 10993-1 EN ISO 10993-1:2009 and EN ISO 10993-1:2009/AC:2010ISO 10993-1:2009 and ISO 10993-1:2009/Cor 1:2010ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009ISO 10993-18 EN ISO 10993-18:2009 ISO 10993-18:2005ISO 1

20、1607-1 EN ISO 11607-1:2017 ISO 11607-1:2006 and ISO 11607-1:2006/Amd 1:2014ISO 14155 EN ISO 14155:2011 and EN ISO 14155:2011/AC:2011ISO 14155:2011 and ISO 14155:2011/Cor. 1:20112BS EN ISO 14607:2018EN ISO 14607:2018 (E)Normative references as listed in Clause 2 of the ISO standardEquivalent dated st

21、andardEN ISO or IECISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012Endorsement noticeThe text of ISO 14607:2018 has been approved by CEN as EN ISO 14607:2018 without any modification.3BS EN ISO 14607:2018EN ISO 14607:2018 (E)Annex ZA (informative) Relationship between this European Standard and the E

22、ssential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be coveredThis European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential

23、 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 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 th

24、e scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations.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

25、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 possible level, minimized or removed, according to the wording of the corresponding essential requirement.NOTE 2 The manufacturers policy for determining accept

26、able 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 normative references according to the table of references in the European foreword, replacing the references in the core text.NOTE 4 When an Essential Requirem

27、ent does not appear in Table ZA.1, it means that it is not addressed by this European Standard.4BS EN ISO 14607:2018EN ISO 14607:2018 (E)Table ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169Essential Requirements of directive 93/42/EECClause(s)/subclaus

28、e(s) of this ENRemarks/Notes7.5 6.2, 6.3, 6.4, 7.2.2.1 The Essential Requirement is covered with respect to the risk posed by silicone gel leaking from the implant.The standard requires several tests to establish safe composition and properties of silicone gel. Beyond that the standard also requires

29、 several tests to establish the integrity of the implant shell to prevent leaks. Additionally, an evaluation of diffusion of gel through the implant shell is required in 7.3.4.Standard Clause 6.2 covers Directive Annex I, ER 7.5 in respect of cytotoxicity only.Standard Clause 6.3 covers Directive An

30、nex I, ER 7.5 in respect of oligomers, cyclotetrasilox-ane (D4) and cyclopentasiloxane (D5) only.Standard Clause 6.4 covers Directive Annex I, ER 7.5 in respect of the specified metals and in production raw materials only.Standard Clause 7.2.2.1 covers Directive Annex I, ER 7.5 in respect of the int

31、egrity of the implant shell only.9.2, second indent 7.2.2.2.2 The Essential Requirement is covered with respect to a potential external impact on the implant, e.g. due to the safety belt being triggered in a car accident.The standard provides an impact resistance test to make sure implants withstand

32、 such impacts.Standard Clause 7.2.2.2.2. covers Directive Annex I, ER 9.2 second dash in respect of impact resistance of the device only.13.1 11.3, Annex I, Annex J While the references to ISO 14630:2012 in 11.3 point to useful information, they are not considered relevant within the context of this

33、 Annex ZA.Only the requirements provided specifically in this standard should be considered when claiming coverage of the Essential Require-ment with this standard.13.3 a) 11.7.2 a), c), Annex J a) Directive Annex I, ER 13.3 a) is covered in respect of name or trade name and address of the manufactu

34、rer only. The requirement regarding the name and address of authorized representative is not covered.5BS EN ISO 14607:2018EN ISO 14607:2018 (E)Essential Requirements of directive 93/42/EECClause(s)/subclause(s) of this ENRemarks/Notes13.3 b) 11.2 While the references to ISO 14630:2012 in 11.2 point

35、to useful information, they are not considered relevant within the context of this Annex ZA.Only the requirements provided specifically in this standard, which only partly cover the Essential Requirement 13.3 b), should be considered when claiming coverage of the Essential Requirement with this stan

36、dard.13.3 d) 11.7.2 b) 13.3 j) 11.5, Annex I Standard Clause 11.5 covers Directive Annex I, ER 13.3 i) in respect of filling materials only.Standard Annex I covers Directive Annex I, ER 13.3 i) only in respect of the aspects detailed in the standard.13.3 k) Annex I The ER is covered only in respect

37、of the aspects detailed in the standard.13.6.d) Annex I h) Standard Annex I h) covers Directive Annex I, 13.6 d) provided the information is in the instructions for use.13.6 e) 11.6, Annex J c), d), h) Standard Clause 11.6 and Annex J c) and d) cover Directive Annex I, ER 13.6 e) only in respect of

38、expected lifetime.Standard Annex J h) covers Directive Annex I, ER 13.6 e) only in respect of possible effects on breast feeding.13.6. f) 11.3.3, Annex J j), k), l), The ER is covered only in respect of the aspects detailed in the standard.13.6 l) Annex J l) Standard Annex J l) covers Directive Anne

39、x I, 13.6 l) provided the information is in the in-structions for use and is given to the patient.WARNING 1 Presumption of conformity stays valid only 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 sta

40、ndard should consult frequently the latest list published in the Official Journal of the European Union.WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard.6BS EN ISO 14607:2018ISO 14607:2018Foreword ixIntroduction x1 Scope . 12 Normative ref

41、erences 13 Terms and definitions . 14 Intended performance . 35 Design attributes 36 Materials . 36.1 General . 36.2 Cytotoxicity 46.3 Residual low molecular weight oligomers 46.4 Trace elements 46.5 Physico-mechanical properties and characterization . 46.6 Documentation of materials 47 Design evalu

42、ation 57.1 General . 57.2 Pre-clinical evaluation 57.2.1 General 57.2.2 Mechanical tests . 57.2.3 Physical evaluation 67.2.4 Chemical evaluation 77.2.5 Biological evaluation 77.3 Clinical evaluation 77.4 Post-market surveillance . 78 Manufacturing . 79 Sterilization . 710 Packaging . 711 Information

43、 supplied by the manufacturer . 811.1 General . 811.2 Product labelling . 811.3 Information for the user . 811.3.1 General 811.3.2 Resterilization 811.3.3 Effects on diagnostic techniques 811.4 Marking on implants 811.5 Filling materials . 811.6 Information on expected lifetime . 811.7 Information f

44、or the patient 911.7.1 General 911.7.2 Patient record label . 911.7.3 Patient card . 9Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels .10Annex B (normative) Tests for shell integrity 14Annex C (normative) Mechanical tests

45、on a mammary implant in its implantable state .17Annex D (normative) Test method for valve competence and injection site competence .23Annex E (normative) Test for silicone gel cohesion (silicone filling materials only) .25 ISO 2018 All rights reserved viiContents PageBS EN ISO 14607:2018ISO 14607:2

46、018Annex F (normative) Test for silicone gel penetration (silicone filling materials only) .27Annex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method 32Annex H (informative) Test for surface characteristics .36Annex I (normative) Information for the user

47、 39Annex J (normative) Information for the patient .40Bibliography .41viii ISO 2018 All rights reservedBS EN ISO 14607:2018ISO 14607:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

48、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. International organizations, governmental and non-governmental, in liaiso

49、n 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 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 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/direct