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- Withdrawn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
- 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 12010:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Joint replacement implants - Particular requirements". This standard covers: 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.
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.
EN 12010:1998 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 12010:1998 has the following relationships with other standards: It is inter standard links to EN ISO 21534:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12010:1998 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.
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Standards Content (Sample)
SLOVENSKI STANDARD
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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