SN EN 12523 : 1999
Current
The latest, up-to-date edition.
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
12-01-2013
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
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