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CEN

EN 12010:1998

(Main)

Non-active surgical implants - Joint replacement implants - Particular requirements

Non-active surgical implants - Joint replacement implants - Particular requirements

This European Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants.  It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.  Some tests required to demonstrate compliance with this standard are contained in or referenced in level 3 standards.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen

Diese Norm legt besondere Anforderungen für Implantate zum totalen und partiellen Gelenkersatz, für künstliche Bänder und Knochenzement fest, die im folgenden als Implantate bezeichnet werden. Für die Anwendung dieser Norm werden künstliche Bänder und die zu ihnen gehörenden Befestigungsmittel in den Begriff der Implantate eingeschlossen und werden im folgenden als solche bezeichnet. Sie legt Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Verpackung und Bereitstellung von Informationen durch den Hersteller fest.

Implants chirurgicaux non actifs - Prothèses articulaires - Exigences particulières

La présente norme fixe les exigences particulières relatives aux prothèses articulaires totales et partielles et aux ligaments artificiels et au ciment pour os référencés comme implants dans le reste du texte. Pour les besoins de la présente norme, le terme "implant" englobe les ligaments artificiels et les dispositifs de fixation qui y sont associés, référencés ci-après comme implants.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 fournis.

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve

General Information

Status
Withdrawn
Publication Date
17-Feb-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 12010:2000 - Non-active surgical implants - Joint replacement implants - Particular requirements

Relations

Replaced By
EN ISO 21534:2007 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
Effective Date
22-Dec-2008

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EN 12010:2000
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SLOVENSKI STANDARD
SIST EN 12010:2000
01-januar-2000
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve
Non-active surgical implants - Joint replacement implants - Particular requirements
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen
Implants chirurg
...

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