UNI EN 12523 : 2001

Foreword
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Requirements for materials
6 Noise and vibration
7 Electromagnetic compatibility (EMC)
8 Electrical safety
9 Surface temperature
10 Sterility
11 Design requirements
12 Mechanical requirements
13 Information supplied by the manufacturer
14 Packaging
Annex A (informative) Guidance on methods of determining
the strength of upper limb prosthetic devices
Annex B (normative) Method of determining the mechanical
properties of knee joint assemblies for lower limb orthotic
devices
Annex C (informative) Guidance on methods of determining
the flammability and toxicity of combustion products of
lower limb prosthetic devices
Annex D (informative) Guidance on methods of establishing
the force required to operate the controls on prosthetic and
orthotic devices
Annex E (informative) Bibliography
Annex Z (informative) Clauses of this European Standard
addressing essential requirements or other provisions of EU
Directives

Covers test methods and requirements for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999: 06 03 - 06 15 Orthoses, 06 18 - 06 27 Limb prostheses. Covers materials, strength, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. Does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body-worn.