EN 12006-2:1998+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

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.

Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen

Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 2 : Prothèses vasculaires y compris les conduits valvulés

La présente norme spécifie les exigences particulières relatives aux prothèses vasculaires y compris les conduits
valvulés d'origine synthétique ou biologique destinés à remplacer, reconstruire, réaliser des pontages ou des
dérivations entre diverses parties du système cardio-vasculaire humain.
La présente norme ne s'applique pas aux prothèses issues de tissus hôtes (autogreffes).
NOTE Un conduit valvulé est une prothèse combinée et entre dans le domaine d'application de la présente norme.
En ce qui concerne la sécurité, et en complément de l'EN ISO 14630:1997, elle présente les exigences relatives
aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la
stérilisation, à l'emballage et aux instructions fournies par le fabricant.
La présente norme spécifie la désignation des matériaux servant à la fabrication et à la construction ainsi que la
désignation des tailles et des dimensions des prothèses vasculaires. Elle fait référence aux exigences biologiques
relatives aux matériaux servant à la fabrication et aux produits finis en prenant en compte les normes internationales
et européennes appropriées.
La présente norme spécifie également la désignation des propriétés mécaniques. Elle décrit les méthodes de
mesurage et de vérification des dimensions et des propriétés mécaniques déclarées par le fabricant, y compris l'essai
de durabilité.
La présente norme spécifie également les exigences relatives à l'emballage et à l'étiquetage. Elle donne également
les définitions des termes d'usage courant.
La présente norme ne spécifie pas toutes les caractéristiques de performances ou de dimensions. Dans des
cas semblables, elle donne cependant les méthodes permettant de vérifier les valeurs nominales données
par le fabricant.

Neaktivni kirurški vsadki (implantati) - Posebne zahteve za srčnožilne vsadke (kardiovaskularne implantate) - 2. del: Žilne proteze, vključno s cevastimi vsadki s srčnimi zaklopkami (tubularnimi grafti)

General Information

• Status: Withdrawn
• Publication Date: 05-May-2009
• Withdrawal Date: 28-Feb-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 3 - Cardiac and vascular implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 01-Mar-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12006-2:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

Relations

• Merged From: EN 12006-2:1998/prA1 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 18-Jan-2023
• Merged From: EN 12006-2:1998 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 23-Mar-2009
• Replaced By: EN ISO 7198:2017 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
• Effective Date: 08-Mar-2017

Standards Content (Sample)

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
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

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

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.
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 European and the future international standard aligned, the table at the informative Annex C indicates for a clause of this European Standard, where the text of a requirement can be found in the corresponding ISO/DIS 7198. 3 Definitions For the purposes of this European Standard the definitions in EN ISO 14630:1997 and ISO/DIS 7198 apply together with the following: SIST EN 12006-2:2000+A1:2009
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