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CEN

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Withdrawn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
ICS
11.180 - Aids for disabled or handicapped persons
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 - 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 12523:2000 - External limb prostheses and external orthoses - Requirements and test methods

Relations

Replaced By
EN ISO 22523:2006 - External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
Effective Date
22-Dec-2008

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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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SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SIST EN 12523:2000



SI
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