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CEN

EN 12564:1998

(Main)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants

Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants

This European Standard provides specific requirements for knee joint replacement implants.  With regard to safety, the standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Kniegelenkersatz

Diese Europäische Norm legt spezielle Anforderungen an Implantate für den Kniegelenkersatz fest. In Bezug auf die Sicherheit legt diese Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren, fest.

Implants chirurgicaux non actifs - Prothèses de l'articulation du genou - Exigences spécifiques relatives aux prothèses de l'articulation du genou

La présente norme européenne fournit des exigences spécifiques relatives aux prothèses de l'articulation du genou.  En matière de sécurité, elle fournit des 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 devant être fournies par le fabricant de même que les méthodes d'essai.

Neaktivni kirurški vsadki (implantati) - Kolenske proteze - Posebne zahteve za kolensko protezo

General Information

Status
Withdrawn
Publication Date
15-Dec-1998
Withdrawal Date
14-Sep-2007
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 4 - Joint replacement and tools and accessories
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Sep-2007
Completion Date
15-Sep-2007
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 12564:2000 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants

Relations

Replaced By
EN ISO 21536:2007 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
SIST EN 12564:2000
01-januar-2000
Neaktivni kirurški vsadki (implantati) - Kolenske proteze - Posebne zahteve za
kolensko protezo
Non-active surgical implants - Joint replacement implants - Specific requirements for
knee joint replacement implants
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Kniegelenkersatz
...

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