EN ISO 14607-2009 en Non-active surgical implants - Mammary implants - Particular requirements《非活性外科植入物 乳房植入物 特殊要求》.pdf

1、BS EN ISO 14607:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNon-active surgical implants Mammary implants Particular requirementsThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November

2、 2009. BSI 2009ISBN 978 0 580 68133 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 14607:2009National forewordThis British Standard is the UK implementation of EN ISO 14607:2009.It is identical to ISO 14607:2007. It supersedes BS EN ISO 14607:2007which is withdrawn.The UK part

3、icipation in its preparation was entrusted to TechnicalCommittee CH/150, Implants for surgery.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible

4、 for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14607May 2009ICS 11.040.40 Supersedes EN ISO 14607:2007 English VersionNon-active surgical implants - Mammary implants - Particularrequir

5、ements (ISO 14607:2007)Implants chirurgicaux non actifs - Implants mammaires -Exigences particulires (ISO 14607:2007)Nichtaktive chirurgische Implantate - Mammaimplantate -Besondere Anforderungen (ISO 14607:2007)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to com

6、ply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Manageme

7、nt 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theoff

8、icial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slov

9、enia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN nation

10、al Members.Ref. No. EN ISO 14607:2009: EBS EN ISO 14607:2009EN ISO 14607:2009 (E) 3 Foreword The text of ISO 14607:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14607:2009

11、by 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 text or by endorsement, at the latest by November 2009, and conflicting national st

12、andards shall be withdrawn at the latest by March 2010. 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 IS

13、O 14607:2007. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document

14、. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy

15、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14607:2007 has been approved by CEN as a EN ISO 14607:2009 without any modification. BS EN ISO 14607:2009E

16、N ISO 14607:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a mea

17、ns of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with th

18、e clauses of this standard given in table ZA 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 regulations. Table ZA Correspondence between this European Standard and Directive 93/

19、42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1 - 2 - 3 - 4 - 7.1 5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2 7 1 - 2 - 3 - 4 - 5 - 6 - 6.a - 7.1 - 7.2 -

20、 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 8 1 - 2 - 3 - 5 - 7.1 - 7.2 9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4 10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6 11 1 - 2 - 13 Subclause 11.7 requires that the information detailed in Annex F be given to the patient by the medical staff, in accordance with the Essential Requirements 1

21、3.6 k) and l). The part of ER 13.3.a concerning the information on the authorized representative is not addressed in this European Standard ER 13.6.q) This relevant Essential Requirement is not addressed in this European Standard. WARNING Other requirements and other EU Directives may be applicable

22、to the product(s) falling within the scope of this standard. BS EN ISO 14607:2009ISO 14607:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Intended performance 2 5 Design attributes. 2 6 Materials 3

23、7 Design evaluation . 3 7.1 General. 3 7.2 Pre-clinical evaluation 3 7.3 Clinical evaluation 6 7.4 Post-market surveillance . 7 8 Manufacturing . 7 9 Sterilization 7 10 Packaging 7 11 Information supplied by the manufacturer 7 11.1 General. 7 11.2 Resterilization . 8 11.3 Base dimensions 8 11.4 Effe

24、cts on diagnostic techniques . 8 11.5 Filling materials. 8 11.6 Information on expected lifetime 8 11.7 Information for the patient . 8 11.8 Labels. 9 11.9 Information for the user . 9 11.10 Marking on implants. 9 11.11 Manufacturers device card . 9 Annex A (normative) Test for surface characteristi

25、cs . 10 Annex B (normative) Tests for shell integrity . 11 Annex C (normative) Test method for valve competence and injection site competence. 13 Annex D (normative) Test for silicone gel cohesion (silicone filling materials only) . 15 Annex E (normative) Mechanical tests on a mammary implant in its

26、 implantable state 17 Annex F (normative) Information for the patient 22 Annex G (normative) Information for the user 24 Annex H (informative) Silicone release assessment from mammary implants by an in vitro method . 25 Bibliography . 28 BS EN ISO 14607:2009ISO 14607:2007(E) iv ISO 2007 All rights r

27、eservedForeword ISO (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 wh

28、ich 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 work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

29、matters of electrotechnical 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 ci

30、rculated to the member bodies 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 respo

31、nsible for identifying any or all such patent rights. ISO 14607 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in collaboration with Technical Committee ISO/TC 150, Implants for surgery, in accordance with the Agreement

32、on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 14607:2002), which has been technically revised. BS EN ISO 14607:2009ISO 14607:2007(E) ISO 2007 All rights reserved vIntroduction In addition to the requirements given in

33、the level 1 standard, this International Standard provides a method for addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate compliance with the relevant Essential Requirements as outlined in general t

34、erms in Annex I of the Directive 93/42/EEC of 14 June 1993 concerning medical devices (amended by the Commission Directive 2003/12/CE), as they apply to mammary implants for use in clinical practice. Further specific information on mammary implants indicating how to comply with the Directive 93/42/E

35、EC is given by the Communication from the European Commission on community and national measures in relation to mammary implants. There are three levels of European Standards dealing with non-active surgical implants. These are as follows (with level 1 being highest): Level 1: General requirements f

36、or non-active surgical implants; Level 2: Particular requirements for families of non-active surgical implants; Level 3: Specific requirements for types of non-active surgical implants. This is a level 2 standard and contains particular requirements for a family of mammary implants. The level 1 stan

37、dard, ISO 14630, contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. To address all requirements, it is necessary to start with a standard of the lowest available level. BS EN ISO 14607:2

38、009BS EN ISO 14607:2009INTERNATIONAL STANDARD ISO 14607:2007(E) ISO 2007 All rights reserved 1Non-active surgical implants Mammary implants Particular requirements 1 Scope This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety,

39、 this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. 2 Normative references The following referenced documents are indispensable for the app

40、lication 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 34-1:2004, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and cresc

41、ent test pieces ISO 37, Rubber, vulcanized or thermoplastic Determination of tensile stress-strain properties ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 14155-1:2003, Clinical investigation of medical devices for human subjects Part 1: General requiremen

42、ts ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ISO 14630:1), Non-active surgical implants General requirements NF S 99-401:1994, Medical devices Silicone elastomer of medical grade NOTE The Bibliography gives informative references t

43、o other useful standards. 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 14155-1, ISO 14155-2 and ISO 14630 and the following apply. 3.1 anterior projection maximum height of the implant when placed with its base on a flat horizontal su

44、rface at its nominal volume 1) To be published. (Revision of ISO 14630:2005) BS EN ISO 14607:2009ISO 14607:2007(E) 2 ISO 2007 All rights reserved3.2 base dimensions length of the major axis and the length of the minor axis when the implant is placed with its base on a flat horizontal surface at its

45、nominal volume 3.3 diffusion movement of material in and/or out of an implant through an intact shell 3.4 injection site component designed to be penetrated by a needle to alter the volume of the implant 3.5 mammary implant implant with a shell which is filled by the manufacturer or the surgeon and

46、is designed to add to or replace volume of the breast 3.6 orientation means mark in or on the implant to assist the surgeon in positioning the implant 3.7 release movement out of an implant of material originating from the filling material or the shell, or products resulting from the interaction of

47、the two 3.8 shell envelope of the implant 3.9 seam seal junction of materials fused or adhered together 3.10 valve component of the shell into which an accessory is inserted to inflate variable volume implants 4 Intended performance The requirements of ISO 14630:, Clause 4, apply. Specific attention

48、 shall be paid to ensure that the clinical condition and safety of the patient are not compromised during the expected lifetime of the device under conditions of normal use. NOTE 1 Information on expected duration of intended performances is given in 11.6. NOTE 2 Information on the nature of the ben

49、efit expected from a mammary implant is given in 7.2. NOTE 3 Information on specific risks related to the mammary implant is given in Clauses 5, 6 and 7. 5 Design attributes The requirements of ISO 14630:, Clause 5, apply. BS EN ISO 14607:2009ISO 14607:2007(E) ISO 2007 All rights reserved 3In order to meet the intended performance requirements, the design attributes shall take into account the ability to detect rupture. The effect of ageing of materials shall be investigated. 6 Materials The requirements of ISO 14630: