SIST EN 12006-2:2000+A1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlich Herzklappen-GefäßstutzenImplants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 2 : Prothèses vasculaires y compris les conduits valvulésNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 12006-2:1998+A1:2009SIST EN 12006-2:2000+A1:2009en,fr,de01-julij-2009SIST EN 12006-2:2000+A1:2009SLOVENSKI
STANDARD



SIST EN 12006-2:2000+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12006-2:1998+A1
May 2009 ICS 11.040.40 Supersedes EN 12006-2:1998English Version
Non active surgical implants - Particular requirements for cardiacand vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 2 : Prothèses vasculaires y compris les conduits valvulés
Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlich Herzklappen-GefäßstutzenThis European Standard was approved by CEN on 16 January 1998 and includes Amendment 1 approved by CEN on 5 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 12006-2:1998+A1:2009: ESIST EN 12006-2:2000+A1:2009



EN 12006-2:1998+A1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Definitions .54Intended performance .65Design attributes.66Materials .67Design evaluation .68Manufacturing .89Sterilization .810Packaging .811Information supplied by the manufacturer .8Annex A (normative)
Classification of prostheses .9Annex B (informative)
Bibliography . 10Annex C (informative)
Reference table EN 12006-2 and ISO/DIS 7198 . 11Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 13 SIST EN 12006-2:2000+A1:2009



EN 12006-2:1998+A1:2009 (E) 3 Foreword This document (EN 12006-2:1998+A1:2009) has been prepared 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. This document includes Amendment 1, approved by CEN on 2009-04-05. This document supersedes EN 12006-2:1998. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This European Standard 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. 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 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 requirements that apply to non-active surgical implants in the family of vascular prostheses including cardiac valve conduits. The level 1 standard 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. The level 1 standard has been published as EN ISO 14630:1997. Level 3 standards apply to specific types of implants within a family such as bone plates and hip joints. To address all requirements, it is recommended to start with a standard of the lowest available level. References to other European or international standards can also be found in Annex B "Bibliography". 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 United Kingdom.
SIST EN 12006-2:2000+A1:2009



EN 12006-2:1998+A1:2009 (E) 4 Introduction This European Standard, provides in addition to the requirements in EN ISO 14630:1997, a method to demonstrate compliance with the relevant Essential Requirements 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 vascular prostheses including cardiac valve conduits. It should be read in conjunction with the EN ISO 14630:1997. In addition to the requirements of EN ISO 14630:1997, this European Standard is for a major part based on ISO/DIS 7198. Furthermore, it gives requirements not given in EN ISO 14630:1997 or ISO/DIS 7198.
SIST EN 12006-2:2000+A1:2009



EN 12006-2:1998+A1:2009 (E) 5 1 Scope This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans. This European Standard is not applicable to prostheses derived from host tissue (autografts). NOTE A valve conduit is regarded as a composite prosthesis and falls within the scope of this standard. With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate International and European Standards. In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by the manufacturer, including durability testing. This standard also gives requirements for packaging and labelling. It provides definitions of the terms in common use. This European Standard does not specify all possible performance or dimensional characteristics. In such cases, the European Standard does however include methods to verify the nominal values stated 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. prEN 12006-1, Non-active surgical implants – Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes EN ISO 14630:1997, Non-active surgical implants – General requirements (ISO 14630:1997) ISO/DIS 7198, Cardiovascular implants – tubular vascular prostheses NOTE 1 Annex B gives informative references to other useful standards. NOTE 2 This standard refers to many items of ISO/DIS 7198. In order to keep the Eu
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