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1、BS EN ISO 14607:2007 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Non-active surgical implants Mammary implants Particular requirements (ISO 14607:2007) Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Unco
2、ntrolled Copy, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2008 BSI 2008 ISBN 978 0 580 55458 2 Amendments/corrigenda issued since publication DateComments BS EN ISO 14607:2007 National foreword This British Standard i
3、s the UK implementation of EN ISO 14607:2007. It supersedes BS EN 12180:2000 which is withdrawn.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 secretar
4、y. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed Copy: London South Bank University, South Bank University, 31/01/2
5、009 03:03, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14607 February 2007 ICS 11.040.40Supersedes EN 12180:2000 English Version Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) Implants chirurgicaux non actifs - Impla
6、nts mammaires - Exigences particulires (ISO 14607:2007) Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007) This European Standard was approved by CEN on 4 February 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip
7、ulate 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 Management Centre or to any CEN member. This European Standard
8、 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 Management Centre has the same status as the official versions. CEN members are the national standa
9、rds 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, Slovenia, Spain, Sweden, Switzerland and United King
10、dom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14607:2007: E
11、Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007 EN ISO 14607:2007 (E) 3 ANNEX ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devic
12、es This International Standard has been prepared under a mandate given to CEN by the European Commission to provide one means of conforming to the Essential Requirements of the New Approach Directive 93/42/EEC Medical Devices. Once this standard is cited in the Official Journal of the European Commu
13、nities under that Directive and has been implemented as a national standard in at least one Member State, 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
14、Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC Medical Devices Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes
15、 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 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 - 14 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
16、.3 - 8.6 11 1 - 2 - 13 11.6 requires that the information detailed in Annex F be given to the patient by the medical staff, in accordance with the Essential Requirements 13.6 k) and l). WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope o
17、f this standard. Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 ISO 14607:2007(E) ISO 2007 All rights reserved v Introduction In addition to the requirements given in the level 1 standard, this
18、 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 terms in Annex I of the Dir
19、ective 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/EEC is given by the Communi
20、cation 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 for non-active surgical imp
21、lants; 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 standard, ISO 14630, contains
22、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. Licensed Copy: London South Bank University
23、, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 INTERNATIONAL STANDARD ISO 14607:20
24、07(E) ISO 2007 All rights reserved 1 Non-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, this International Standard specifies requirements for i
25、ntended 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 application of this document. For dated references, only the
26、 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 test pieces ISO 37, Rubber, vulcanized or thermoplast
27、ic 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 14155-2, Clinical investigation of medical devices
28、 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 useful standards. 3 Terms and definitions For the
29、 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 at its nominal volume 1) To be published. (Revision
30、 of ISO 14630:2005) Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 ISO 14607:2007(E) 2 ISO 2007 All rights reserved 3.2 base dimensions length of the major axis and the length of the minor axis
31、 when the implant is placed with its base on a flat horizontal surface at its 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 implan
32、t implant with a shell which is filled by the manufacturer or the surgeon and 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
33、 filling material or the shell, or products resulting from the interaction of 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 p
34、erformance The requirements of ISO 14630:, Clause 4, apply. Specific attention 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 inten
35、ded performances is given in 11.6. NOTE 2 Information on the nature of the benefit 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.
36、 Licensed Copy: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 ISO 14607:2007(E) ISO 2007 All rights reserved 3 In order to meet the intended performance requirements, the design attributes shall take into ac
37、count 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 to biological evaluation of the device and
38、 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 used under the conditions and for the purpose
39、 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 to the patient, taking into account the fac
40、t 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 implant. 7.2 Pre-clinical evaluation 7.2.
41、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 sample preparation used shall be documented b
42、y 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 docu
43、mented. 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 materials other than silicone, the manufacturer should consider and develop tests as indicated in 7.2.2. Licensed Co
44、py: London South Bank University, South Bank University, 31/01/2009 03:03, Uncontrolled Copy, (c) BSI BS EN ISO 14607:2007BS EN ISO 14607:2007 ISO 14607:2007(E) 4 ISO 2007 All rights reserved 7.2.2 Mechanical tests 7.2.2.1 General Mechanical tests shall be conducted in accordance with Annexes A, B,
45、C, D and E and shall comply with the stated requirements. The goal of mechanical tests is to ensure a low rupture rate of the device under normal conditions of use. 7.2.2.2 Shell integrity 7.2.2.2.1 General The integrity of the shell shall be evaluated. The following properties of the silicone elast
46、omer shell shall be tested in accordance with Annex B and shall comply with the stated requirements. A worst-case assumption should be considered. For materials other than silicone elastomer, relevant tests shall be developed. 7.2.2.2.2 Elongation The elongation of the silicone elastomer shell shall
47、 be tested in accordance with B.1 and shall comply with the stated requirements. 7.2.2.2.3 Tear resistance The tear resistance shall be tested in accordance with B.1. 7.2.2.2.4 Strength of joints, seams or seals The resistance to failure of joints, seams and seals shall be tested in accordance with
48、B.2 and shall comply with the stated requirements. 7.2.2.2.5 Design of shell Care shall be taken when selecting materials to be used in the manufacture of the shell. Surfaces both inside and outside the shell shall be suitable to minimize or prevent frictional abrasion both between shell-to-shell su
49、rface and between shell surface and the implantation site. If such frictional abrasion is likely to be a significant problem, the manufacturer shall indicate any relevant tests carried out to ensure the suitability of the shell when implanted. 7.2.2.3 Valve or injection site competence The competence of the valve or injection site shall be tested in accordance with Annex C and shall comply with the stated requirements. 7.2.2.4 Filling material 7.2.2.4.1 General The physical compatibility between the filling materi