EN 12563:1998
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants
Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants
This European Standard provides specific requirements for hip 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 Hüftgelenkersatz
Diese Europäische Norm legt spezielle Anforderungen an Implantate für den Hüftgelenkersatz fest. Mit 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 de la hanche - Exigences spécifiques relatives aux prothèses de l'articulation de la hanche
La présente norme européenne fournit des exigences spécifiques relatives aux prothèses de l'articulation de la hanche. 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) - Sklepne proteze - Posebne zahteve za umetni kolk
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- Withdrawn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
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12563:1998 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 hip joint replacement implants". This standard covers: This European Standard provides specific requirements for hip 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 hip 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 12563:1998 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 12563:1998 has the following relationships with other standards: It is inter standard links to EN ISO 21535:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12563:1998 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 12563:1998 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) - Sklepne proteze - Posebne zahteve za
umetni kolk
Non-active surgical implants - Joint replacement implants - Specific requirements for hip
joint replacement implants
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz
Implant
...
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