EN 12523:1999
(Main)External limb prostheses and external orthoses - Requirements and test methods
External limb prostheses and external orthoses - Requirements and test methods
This European Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999 : 06 03 - 06 1 5 Orthoses 06 18 - OG 27Limb prostheses It covers strength1 materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This European Standard does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body worn. NOTE 1: It is intended to cover orthopaedic foot-wear (classification 06 33) in the future. NOTE 2: The application of Quality Systems as described or referred to in EN 46001 and EN 46002 may be appropriate.
Externe Gliedmaßenprothesen und externe Orthesen - Anforderungen und Prüfverfahren
Diese Europäische Norm legt die Anforderungen und Prüfverfahren für externe Gliedmaßenprothesen und externe Orthesen fest. Einbezogen sind die folgenden Klassifizierungen nach EN ISO 9999: 06 03 - 06 15 Orthesen und 06 18 - 06 27 Gliedmaßenprothesen. Sie befaßt sich mit Festigkeit, Werkstoffen, Einschränkungen im Gebrauch, Risiken und der Bereitstellung von Informationen über die normalen Gebrauchsbedingungen für Einzelbauteile und Baugruppen.
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai
La présente norme européenne spécifie les exigences et les méthodes d'essai applicables aux prothèses de membre externes et orthèses externes, y compris les classifications suivante de l'EN ISO 9999: 06 03 - 06 15 Orthèses, 06 18 - 06 27 Prothèses de membre. La présente norme spécifie la résistance, les matériaux utilisés, les restrictions d'utilisation, les risques et les informations associés aux conditions normales d'utilisation des composants et des ensembles de composants.
Zunanje proteze za ude in zunanje ortoze - Zahteve in preskusne metode
General Information
- Status
- Withdrawn
- Publication Date
- 19-Jan-1999
- Withdrawal Date
- 30-Sep-2006
- Technical Committee
- CEN/TC 293 - Technical aids for disabled persons
- Drafting Committee
- CEN/TC 293/WG 5 - Prosthoses and orthoses
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 01-Oct-2006
- Completion Date
- 01-Oct-2006
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12523:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "External limb prostheses and external orthoses - Requirements and test methods". This standard covers: This European Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999 : 06 03 - 06 1 5 Orthoses 06 18 - OG 27Limb prostheses It covers strength1 materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This European Standard does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body worn. NOTE 1: It is intended to cover orthopaedic foot-wear (classification 06 33) in the future. NOTE 2: The application of Quality Systems as described or referred to in EN 46001 and EN 46002 may be appropriate.
This European Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999 : 06 03 - 06 1 5 Orthoses 06 18 - OG 27Limb prostheses It covers strength1 materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This European Standard does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body worn. NOTE 1: It is intended to cover orthopaedic foot-wear (classification 06 33) in the future. NOTE 2: The application of Quality Systems as described or referred to in EN 46001 and EN 46002 may be appropriate.
EN 12523:1999 is classified under the following ICS (International Classification for Standards) categories: 11.180 - Aids for disabled or handicapped persons. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12523:1999 has the following relationships with other standards: It is inter standard links to EN ISO 22523:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12523:1999 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 12523:1999 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zunanje proteze za ude in zunanje ortoze - Zahteve in preskusne metodeExterne Gliedmaßenprothesen und externe Orthesen - Anforderungen und PrüfverfahrenProtheses de membre externes et ortheses externes - Exigences et méthodes d'essaiExternal limb prostheses and external orthoses - Requirements and test methods11.180.10JLEDQMHAids and adaptation for moving11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 12523:1999SIST EN 12523:2000en01-januar-2000SIST EN 12523:2000SLOVENSKI
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