EN 12006-1:1999

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes

This standard specifies particular requirements for heart valve substitutes.           This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue.           With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.           This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made.           Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).

Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 1: Herzklappenprothesen

Diese Norm legt besondere Anforderungen für Herzklappenprothesen fest. Diese Europäische Norm gilt nicht für Herzklappenprothesen, die vollständig oder teilweise aus menschlischem Gewebe bestehen. Im Hinblick auf die Sicherheit nennt sie Anforderungen für die vorgesehene Funktion, Konstruktions-merkmale, Werkstoffe, Bewertung der Konstruktion, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen.

Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 1: Prothèses valvulaires cardiaques

La présente norme européenne spécifie les exigences particulières relatives aux prothèses valvulaires cardiaques. La présente norme européenne ne s'applique pas aux prothèses valvulaires cardiaques constituées entièrement, ou en partie, de tissu d'origine humaine. En ce qui concerne la sécurité, 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 informations fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) – Posebne zahteve za srčnožilne vsadke (kardiovaskularne implantate) – 1. del: Nadomestki srčne zaklopke

General Information

• Status: Withdrawn
• Publication Date: 20-Jul-1999
• Withdrawal Date: 13-Dec-2005
• 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: 14-Dec-2005
• Completion Date: 14-Dec-2005
• 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 12006-1:2000 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes

Relations

• Child: 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: 22-Dec-2008
• Child: EN 12006-3:1998 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
• Effective Date: 22-Dec-2008
• Child: EN ISO 7439:2002 - Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 5840:2005 - Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 1: HerzklappenprothesenImplants chirurgicaux non actifs - Exigences particulieres pour les implants cardio-vasculaires - Partie 1: Protheses valvulaires cardiaquesNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 12006-1:1999SIST EN 12006-1:2000en01-julij-2000SIST EN 12006-1:2000SLOVENSKI
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