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- Withdrawn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
- 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
- Not Harmonized93/42/EEC - Medical devicesOJ Ref: C 227, C 227, C 227, C 227, C 227, C 227, C 227, C OJ Date: 10-Aug-1999
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 12564:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants". This standard covers: 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.
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.
EN 12564:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12564:1998 has the following relationships with other standards: It is inter standard links to EN ISO 21536:2007, EN ISO 2503:2009, EN ISO 22435:2007, EN ISO 10524-3:2019, EN ISO 10524-3:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12564:1998 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12564:1998 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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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