EN 12006-2:1998

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 gives also 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

Diese Norm legt besondere Anforderungen für Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen, synthetischer oder biologischer Herkunft fest, die im menschlichen Herz-Gefäß-System zum Ersatz, zur Rekonstruktion, zum Bypassaufbau oder zur Shuntbildung zwischen dessen Teilen bestimmt sind. Diese Eurpäische Norm gilt nicht für Herzklappen-Gefäßstutzen die vollständig oder teilweise aus menschlichem Gewebe bestehen.

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 européenne ne s'applique pas aux prothèses issues de tissus hôtes (autogreffes).

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: 17-Feb-1998
• Withdrawal Date: 05-May-2009
• 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
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• 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 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

Relations

• Parent: EN 12006-1:1999 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
• Effective Date: 22-Dec-2008
• Amended By: 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: 22-Dec-2008
• Merged Into: 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
• Effective Date: 23-Mar-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12006-2:2000
01-januar-2000
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Non active surgical implants - Particular requirements for cardiac and vascular implants -
Part 2: Vascular prostheses including cardiac valve conduits
Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und
Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlic
...