Standard Svensk standard · SS-EN ISO 22523:2006

Extremitetsproteser och ortoser - Krav och provningsmetoder (ISO 22523:2006)

Status: Gällande

Omfattning
This International Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It covers strength, 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 International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn. NOTE 1 It is intended to cover orthopaedic footwear (classification 06 33) in the future. NOTE 2 The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 may be appropriate.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40) Hjälpmedel för personer med funktionsnedsättningar (11.180.01)


Produktinformation

Språk: Engelska

Framtagen av: Ortoser och proteser, SIS/TK 344/AG 02

Internationell titel: External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

Artikelnummer: STD-46728

Utgåva: 1

Fastställd: 2006-10-23

Antal sidor: 92

Ersätter: SS-EN 12523