1、August 2009DEUTSCHE NORM English price group 16No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!$Y6“1541990ww
2、w.din.deDDIN EN ISO 14607Non-active surgical implants Mammary implants Particular requirements (ISO 14607:2007)English version of DIN EN ISO 14607:2009-08Nichtaktive chirurgische Implantate Mammaimplantate Besondere Anforderungen (ISO 14607:2007)Englische Fassung DIN EN ISO 14607:2009-08SupersedesDI
3、N EN ISO 14607:2007-05See start of validitywww.beuth.deDocument comprises 37 pages DIN EN ISO 14607:2009-08 2 Start of validity This standard takes effect on 1 August 2009. DIN EN ISO 14607:2007-05 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Tech
4、nical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics St
5、andards Committee), Technical Committee NA 027-02-17-02 UA Brust-implantate. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International and European Standards referred to in claus
6、e 2 of this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 14155-1 DIN EN ISO 14155-1 ISO 14155-2 DIN EN ISO 14155-2 ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 14607:2007-05 as follows: Annex ZA (informative) concerning the relationship between this Euro
7、pean Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member S
8、tates relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN 12180: 2000-04 DIN EN ISO 14607: 2007-05 a) DIN EN ISO 14607:2009-08 3 National Annex NA (informative) Bibliograp
9、hy DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing (ISO 10993-1:2003) DIN EN ISO 14155-1:2003, Clinical investigation of medical devices for human subjects Part 1: General requirements (ISO 14155-1:2003) DIN EN ISO 14155-2, Clinical investigation of medica
10、l devices for human subjects Part 2: Clinical investigation plans (ISO 14155-2:2003) DIN EN ISO 14630:2005, Non-active surgical implants General requirements (ISO 14630:200 ) 5DIN EN ISO 14607:2009-08 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14607May 2
11、009ICS 11.040.40 Supersedes EN ISO 14607:2007 English VersionNon-active surgical implants - Mammary implants - Particularrequirements (ISO 14607:2007)Implants chirurgicaux non actifs - Implants mammaires -Exigences particulires (ISO 14607:2007)Nichtaktive chirurgische Implantate - Mammaimplantate -B
12、esondere Anforderungen (ISO 14607:2007)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to comply 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
13、-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder t
14、he responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungar
15、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Aven
16、ue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14607:2009: E2 DIN EN ISO 14607:2009-08 EN ISO 14607:2009 (E) Contents Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms an
17、d definitions .5 4 Intended performance.6 5 Design attributes .6 6 Materials .7 7 Design evaluation7 7.1 General .7 7.2 Pre-clinical evaluation.7 7.3 Clinical evaluation.10 7.4 Post-market surveillance11 8 Manufacturing11 9 Sterilization 11 10 Packaging.11 11 Information supplied by the manufacturer
18、 .11 11.1 General .11 11.2 Resterilization 12 11.3 Base dimensions.12 11.4 Effects on diagnostic techniques 12 11.5 Filling materials .12 11.6 Information on expected lifetime .12 11.7 Information for the patient12 11.8 Labels .13 11.9 Information for the user13 11.10 Marking on implants13 11.11 Man
19、ufacturers device card13 Annex A (normative) Test for surface characteristics 14 Annex B (normative) Tests for shell integrity15 Annex C (normative) Test method for valve competence and injection site competence .17 Annex D (normative) Test for silicone gel cohesion (silicone filling materials only)
20、19 Annex E (normative) Mechanical tests on a mammary implant in its implantable state 21 Annex F (normative) Information for the patient .26 Annex G (normative) Information for the user.28 Annex H (informative) Silicone release assessment from mammary implants by an in vitro method29 Bibliography32
21、Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 33 Foreword 3 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)
22、and has been taken over as EN ISO 14607:2009 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
23、by November 2009, and conflicting national standards 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
24、patent rights. This document supersedes EN ISO 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 Z
25、A, 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germ
26、any, Greece, Hungary, Iceland, Ireland, Italy, 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 wi
27、thout any modification. EN ISO 14607:2009 (E) DIN EN ISO 14607:2009-08 Introduction In addition to the requirements given in 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 im
28、plants. It also provides a method to demonstrate compliance with the relevant Essential Requirements as outlined in general terms 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 u
29、se in clinical practice. Further specific information on mammary implants indicating how to comply with the Directive 93/42/EEC 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
30、dealing with non-active surgical implants. These are as follows (with level 1 being highest): Level 1: General requirements for 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
31、 implants. This is a level 2 standard and contains particular requirements for a family of mammary implants. The level 1 standard, 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 stan
32、dards. To address all requirements, it is necessary to start with a standard of the lowest available level. 4 DIN EN ISO 14607:2009-08 EN ISO 14607:2009 (E) 1 Scope This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this I
33、nternational 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 applicatio
34、n 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 crescent tes
35、t 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 requirements ISO
36、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 to other
37、 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 surface a
38、t its nominal volume 1) To be published. (Revision of ISO 14630:2005) 5 EN ISO 14607:2009 (E) DIN EN ISO 14607:2009-08 3.2 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 nominal volume 3.3 diffusi
39、on 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 is designed to add to or r
40、eplace 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 the two 3.8 shell envelope
41、 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 shall be paid to ensure t
42、hat 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 benefit expected from a mamma
43、ry 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. 6 DIN EN ISO 14607:2009-08 EN ISO 14607:2009 (E) In order to meet the intended performance requirements
44、, 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:, Clause 6, apply. In addition, if silicone elastomer is used, NF S 99-401:1994 applies. Special attention shall be given
45、to biological evaluation of the device and its components following implant failure; stability of the material (particularly filling material). 7 Design evaluation 7.1 General The requirements of ISO 14630:, 7.1, apply. Mammary implants shall be designed and manufactured in such a way that, when use
46、d under the conditions and for the purpose intended, they will not compromise the clinical condition, the safety or the health of the patient. Any residual risks or undesirable side-effects that might be associated with their use shall constitute acceptable risks when weighted against the benefits t
47、o the patient, taking into account the fact that their benefit is deemed to be primarily aesthetic and psychological in nature, whether the application is for reconstructive and/or cosmetic purposes. Risk analysis and conformity evaluation shall be performed on the filler material, shell and mammary
48、 implant. 7.2 Pre-clinical evaluation 7.2.1 General The pre-clinical evaluation of mammary implants shall conform to ISO 14630:, 7.2. Where no test is described in this International Standard, or when the test described is not applicable, description for the alternative validated test method and sam
49、ple preparation used shall be documented by the manufacturer. The adequacy of the pass/fail criteria adopted for the evaluation shall be verified prior to testing. All testing shall be performed on finished sterilised devices or components. The sample size selected shall be based on a statistical rationale, which shall be justified and documented. NOTE With regard to validated test methods available for the pre-clinical evaluation, this International Standard reflects the present state of the art. Where appropriate, for material
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