I.S. EN 12523:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
10-27-2006
English
01-01-1999
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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