1、June 2012 Translation by DIN-Sprachendienst.English price group 12No part of this translation 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 1
2、1.040.40!$|vj“1898371www.din.deDDIN EN ISO 14602Non-active surgical implants Implants for osteosynthesis Particular requirements (ISO 14602:2010)English translation of DIN EN ISO 14602:2012-06Nichtaktive chirurgische Implantate Implantate zur Osteosynthese Besondere Anforderungen (ISO 14602:2010)Eng
3、lische bersetzung von DIN EN ISO 14602:2012-06Implants chirurgicaux non actifs Implants pour ostosynthse Exigences particulires (ISO 14602:2010)Traduction anglaise de DIN EN ISO 14602:2012-06SupersedesDIN EN ISO 14602:2010-08www.beuth.deIn case of doubt, the German-language original shall be conside
4、red authoritative.Document comprises 21 pages05.12 DIN EN ISO 14602:2012-06 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 5 “Osteosynthesis and spinal devices” in collaboration with
5、 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 Standards Committee), Working Committee NA 027-02-15 AA Endoprothetik und
6、 Osteosynthese. The DIN Standard corresponding to the International Standard referred to in Clause 2 of this document is as follows: ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 14602:2010-08 as follows: a) Annex ZA “Relationship between this European Standard and the
7、Essential Requirements of EU Directive 93/42/EEC” has been updated. Previous editions DIN EN ISO 14602: 1998-08, 2009-08, 2010-08 National Annex NA(informative) Bibliography DIN EN ISO 14630, Non-active surgical implants General requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1
8、4602 October 2011 ICS 11.040.40 Supersedes EN ISO 14602:2010English Version Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) Implants chirurgicaux non actifs - Implants pour ostosynthse - Exigences particulires (ISO 14602:2010)Nichtaktive chirurgi
9、sche Implantate - Implantate zur Osteosynthese - Besondere Anforderungen This European Standard was approved by CEN on 20 September 2011. 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 nationa
10、l standard without any alteration. Up-to-date lists and bibliographical references concerning such national 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 versio
11、n 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, Cyprus, Cze
12、ch 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 Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brus
13、sels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14602:2011: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 14602:2010) Contents Page Foreword . 3 Introductio
14、n . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 5 4 Intended performance . 5 4.1 General 5 4.2 Intended purpose . 6 4.3 Functional characteristics . 6 4.4 Intended conditions of use . 7 5 Design attributes 7 6 Materials 8 7 Design evaluation. 8 7.1 General 8 7.2 Pre-clinical evalu
15、ation . 8 7.3 Clinical evaluation 8 7.4 Post-market surveillance . 8 8 Manufacturing . 9 9 Sterilization . 9 10 Packaging . 9 11 Information supplied by manufacturer 9 11.1 General 9 11.2 Labelling 9 11.3 Instructions for use 9 11.4 Restrictions on combinations . 9 11.5 Marking on implant 9 11.6 Mar
16、king for special purposes . 9 Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 14283 . 10 Annex B (informative) ISO standards referring to implants and associated instruments found acceptable through clinical use for
17、given applications in osteosynthesis 11 Annex C (informative) ISO Standards referring to materials found acceptable through proven clinical use 14 Annex D (informative) Standards related to testing and design evaluation 16 Bibliography 17 Annex ZA (informative) Relationship between this European Sta
18、ndard and the Essential Requirements of EU Directive 93/42/EEC 18 2DIN EN ISO 14602:2012-06 EN ISO 14602:2011 (E) Foreword This document (EN ISO 14602:2011) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration with Technical Committee CEN/TC 285 “Non-active sur
19、gical 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 April 2012, and conflicting national standards shall be withdrawn at the latest by April 20
20、12. 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 14602:2010. This new edition contains a revised An
21、nex ZA. 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Acco
22、rding 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, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, It
23、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14602:2010 has been approved by CEN as EN ISO 14602:2011 without any modification. 3DIN EN ISO 14602:20
24、12-06 EN ISO 14602:2011 (E) Introduction In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone healing or fusion and/or to provide suppor
25、t or correction. When they have achieved their objective, the implants are either retrieved or left in situ. This International Standard, in addition to the requirements in ISO 14630, provides a method for addressing the fundamental principles in ISO/TR 14283 as they apply to non-active surgical imp
26、lants for osteosynthesis. Annex A shows the correspondence between the clauses of this International Standard and those of ISO/TR 14283:2004. This International Standard also provides a method of demonstrating compliance with the relevant essential requirements (ERs) as outlined in general terms in
27、Annex 1 of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, amended by Directive 2007/47/EC of 5 September 2007, as they apply to non-active surgical implants for osteosynthesis. It might also assist manufacturers to comply with the requirements of other regulatory bo
28、dies. Alternative methods of demonstrating compliance might be acceptable, in particular with respect to implants which have demonstrated satisfactory long-term clinical performance. There are three levels of standard concerned with non-active surgical implants and related instrumentation. For the i
29、mplants themselves, there are the following levels, with level 1 being the 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 implants.
30、 Level 1 standards contain requirements that apply to all non-active surgical implants. They also indicate that additional requirements are given in the level 2 and level 3 standards. Level 2 standards, such as this International Standard, contain requirements that apply to a more restricted set or
31、family of non-active surgical implants. This International Standard is a Level 2 standard that lays down particular requirements for non-active surgical implants for osteosynthesis that are in addition to those general requirements stated in ISO 14630 for non-active surgical implants. It is to be ap
32、plied in conjunction with ISO 14630. Level 3 standards, such as those listed in the annexes, apply to specific types of implant within a family of non-active surgical implants, in this case particular types of non-active surgical implant for osteosynthesis. To address all requirements for a specific
33、 implant, it is advisable that the standard of the lowest available level be consulted first. NOTE The requirements in this International Standard correspond to international consensus. Individual or national standards or regulatory bodies can prescribe other requirements. 4DIN EN ISO 14602:2012-06
34、EN ISO 14602:2011 (E) 1 Scope This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design att
35、ributes, 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 edition cited applies. For und
36、ated references, the latest edition of the referenced document (including any amendments) applies. ISO 14630:2008, Non-active surgical implants General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14630 and the following apply. 3.1 no
37、n-active surgical implant for osteosynthesis non-active implantable device intended to provide support to bony, cartilaginous, tendinous or ligamentous structures 4 Intended performance 4.1 General The intended performance of implants shall conform to ISO 14630:2008, Clause 4, taking account of the
38、additional aspects listed in 4.2, 4.3 and 4.4 as applicable. NOTE Because of variations in anatomy, fracture sites and applications, it is necessary that implants for osteosynthesis be versatile. For anatomical reasons the size of the implants is necessarily restricted. The condition of the bone and
39、 the configuration of bony and other defects can affect the performance of the implants. 5DIN EN ISO 14602:2012-06 EN ISO 14602:2011 (E) 4.2 Intended purpose The intended purpose is osteosynthesis, which can include the areas of application listed below. In describing and documenting the implants in
40、tended performance for osteosynthesis, the area(s) of intended typical application(s) shall be specified, for example: a) fracture treatment; b) tumour treatment; c) stabilization of osteotomy; d) stabilization of arthrodesis; e) bone lengthening, shortening or transport; f) support of bone replacem
41、ent (bone graft sites); g) adjunct to joint replacement; h) scoliosis treatment; i) spinal stabilization; j) treatment of degenerative diseases; k) tendon reconstruction; l) ligament reconstruction. NOTE Where appropriate, the anatomical site(s) should be indicated. 4.3 Functional characteristics In
42、 describing and documenting the functional characteristics of the implants, the following aspects shall be addressed as appropriate: a) type of fixation to bony, cartilaginous, tendinous or ligamentous structures; b) means of attachment to or anchorage in bone; c) linkage between implant components
43、and bone or other structures; d) use for revision procedures; e) ability to be removed; f) action on bone and adjacent structures, for example: stabilization; support of the reduction of fractures and dislocations of bone and other structures; correction or control of alignment; transport of fragmen
44、ts; control of compression or distraction; safe placement in relation to adjacent structures. 6DIN EN ISO 14602:2012-06 EN ISO 14602:2011 (E) 4.4 Intended conditions of use Variables that can influence the intended performance of the implant, including the following, shall be taken into account: a)
45、body build (size, weight); b) age of patient; c) pathological conditions; d) bone quality; e) tissue vitality; f) surrounding tissue conditions; g) loading conditions; h) method of implantation; i) interaction and combination with other fixation device; j) activity level of the patient; NOTE Certain
46、 conditions might restrict the application of the implants or call for caution in clinical usage. The performance of the implant might be affected by patient-related conditions. k) operative techniques; l) methods of post-operative treatment. 5 Design attributes The requirements of Clause 5 of ISO 1
47、4630:2008 apply, together with the following particular requirements. a) Where implants are designed as part of an interconnecting system, shape, dimensions and tolerances shall be such that the intended use and performance of the implant is not impaired. NOTE 1 Where an implant comprises two or mor
48、e components, the design should be such that potential wear as well as electrolytic and corrosive effects are taken into account compare with items 5 a), c), h), k) and l) of ISO 14630:2008. b) Where appropriate, the dimensions of the implants shall be consistent with the anatomical features of the population for whom they are intended. NOTE 2 The design of the implants should take into account anatomical structures, types of tissue defect and bone healing/fusion rates. The final design can be a compromise that satisfie
