SVENSK STANDARD SS-EN ISO 14602:2009 Fastställd/Approved: 2009-05-25 Publicerad/Published: 2009-07-02 Utgåva/Edition: 2 Språk/Language: engelska/english ICS: 11.040.40 Icke aktiva kirurgiska implantat Osteosyntesmaterial Särskilda krav (ISO 14602:1998) Non-active surgical implants Implants for Osteosynthesis Particular requirements (ISO 14602:1998) SWEDISH STANDARDS INSTITUTE
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Europastandarden EN ISO 14602:2009 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 14602:2009. Denna standard ersätter SS-EN ISO 14602, utgåva 1. The European Standard EN ISO 14602:2009 has the status of a Swedish Standard. This document contains the official English version of EN ISO 14602:2009. This standard supersedes the Swedish Standard SS-EN ISO 14602, edition 1. Copyright/Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som åter nns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by!the end-user licence for this product. You will nd the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon 08-555 520 00. Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), tel +46 8 555 520 00. Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. SIS Förlag AB, SE 118 80 Stockholm, Sweden. Tel: +46 8 555 523 10. Fax: +46 8 555 523 11. E-mail: sis.sales@sis.se Internet: www.sis.se
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 14602 May 2009 ICS 11.040.40 Supersedes EN ISO 14602:1998 English Version Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998) Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières (ISO 14602:1998) Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere Anforderungen (ISO 14602:1998) 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 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 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 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, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14602:2009: E
SS-EN ISO 14602:2009 (E) Provläsningsexemplar / Preview ISO ISO 14602:1998(E) Contents Foreword Introduction iv v 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Intended performance 1 5 Design attributes 3 6 Materials 3 7 Design evaluation 3 8 Manufacturing 4 9 Sterilization 4 10 Packaging 4 11 Information supplied by the manufacturer 4 Annex A (informative) Annex B (informative) ISO Standards referring to implants and associated instruments found acceptable through clinical use for given applications in osteosynthesis 5 ISO Standards referring to materials found acceptable through proven clinical use 7 Annex C (informative) Standards relating to testing and design evaluation 8 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 9 iii iii
SS-EN ISO 14602:2009 (E) EN ISO 14602:2009 (E) Foreword The text of ISO 14602:1998 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 14602:2009 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 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 patent rights. This document supersedes EN ISO 14602:1998. 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. 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14602:1998 has been approved by CEN as a EN ISO 14602:2009 without any modification. iv3
SS-EN ISO 14602:2009 (E) ISO ISO 14602:1998(E) Introduction This European standard, in addition to the requirements in EN ISO 14630:1997 provides a method to demonstrate compliance with the relevant Essential Requirements (ERs) as outlined in general terms in Annex 1 of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to non-active surgical implants for osteosynthesis. Alternative methods of demonstrating compliance may be acceptable, in particular with respect to implants which have demonstrated satisfactory long-term clinical performance. This Level 2 European Standard lays down particular requirements for osteosynthesis implants, in addition to those general requirements stated in EN ISO 14630:1997 for non-active surgical implants, and shall only be applied in conjunction with EN ISO 14630:1997. In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilise bony (or adjacent) structures to allow bone healing or fusion and/or to provide support or correction. When they have achieved their objective, the implants are either retrieved or left in situ. v v
SS-EN ISO 14602:2009 (E) ISO ISO 14602:1998(E) 1 Scope This European standard specifies particular requirements for non-active surgical Implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN ISO 14630:1997 Non-active surgical implants - General requirements. NOTE: Normative and informative references listed in EN ISO 14630:1997 apply, but are not repeated in this standard. 3 Definitions For the purposes of this European Standard, the definitions in EN ISO 14630:1997 apply together with the following: 3.1 non-active surgical implant for osteosynthesis: Non-active implantable device intended to provide support to bony, cartilaginous, tendinous or ligamentous structures. 4 Intended performance The intended performance of implants shall conform to clause 4 of EN ISO 14630:1997, taking account of the additional aspects as listed in the following 4.1, 4.2 and 4.3 as applicable. NOTE: Because of variations in anatomy, fracture sites and applications, it is necessary that implants for osteosynthesis are versatile. For anatomical reasons the size of the implants is necessarily restricted. The condition of the bone and the configuration of bony and other defects can affect the performance of the implants. 4.1 Functional characteristics In describing and documenting the intended performance of the implants, the following aspects shall be addressed as appropriate: a) type of fixation to bone, cartilaginous, tendinous or ligamentous structures; b) means of attachment to or anchorage in bone; c) linkage between implant components and bone or other structures; d) use for revision procedures; e) ability to be removed; 1
SS-EN ISO 14602:2009 (E) ISO 14602:1998(E) Provläsningsexemplar / Preview ISO f) action on bone and adjacent structures, for example: - stabilization; - restriction or control of movement; - support of the reduction of fractures and dislocations of bone and other structures; - correction or control of alignment; - transport of fragments; - control of compression or distraction; - safe placement in relation to adjacent structures. 4.2 Typical clinical applications In describing and documenting the intended performance of the implants, 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 replacement (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 Conditions of use Physiological or anatomical variables that may influence the intended performance of the implant, including the following, shall be taken into account: a) 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 devices; j) activity level of the patient. NOTE: Certain conditions may restrict the application of the implants or call for caution in clinical usage. The performance of the implant may be affected by patient-related conditions. 2
SS-EN ISO 14602:2009 (E) ISO ISO 14602:1998(E) 5 Design attributes The requirements of clause 5 of EN ISO 14630:1997 apply, together with the following particular requirements. 5.1 Where osteosynthesis 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. 5.2 Where appropriate, the dimensions of the implants shall be consistent with the anatomical features of the population for whom they are intended. NOTE 1: Where an implant comprises two or more components, the design should be such that potential wear, electrolytic and corrosive effects are taken into account [compare with clause 5a), c), e), i) and j) of EN ISO 14630:1997]. NOTE 2: The design of the implants should take into account anatomical structures, types of tissue defects, operative techniques, bone healing, fusion rates, and methods of post operative treatment. The final design may be a compromise to satisfy such diverse requirements. NOTE 3: Annex A contains an informative list of standard implant designs found acceptable through proven use for given applications. 6 Materials The requirements of clause 6 of EN ISO 14630:1997 apply. NOTE: In Annex B an informative list of standards is provided for materials found acceptable for osteosynthesis through proven clinical use. 7 Design evaluation 7.1 General Implants shall be evaluated in accordance with clause 7 of EN ISO 14630:1997, together with the following particular requirements for preclinical evaluation. NOTE: In Annex C (informative) standards are listed that can be used for assessment of compliance with requirements stated above for different types of implants. 7.2 Preclinical evaluation 7.2.1 In vitro handling tests shall be carried out to verify the intended interaction between the implant and the instrumentation, and if appropriate, between interconnecting implants. NOTE: In instances when implantation and, where appropriate, removal cannot be evaluated by direct comparison with existing devices, cadaveric evaluation should be performed where possible. 7.2.2 If static and/or dynamic loading tests are relevant for the evaluation of the implant, either accepted test standards when available, or customized test models taking into account the characteristics of the implant, 3