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.
Registration number (WIID)
14518
Scope
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.
