NS EN 12010 : 1ED 1998

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture and inspection
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) List of materials found acceptable
for the manufacture of implants
Annex B (informative) List of materials found acceptable or
not acceptable for articulating surfaces of implants
Annex C (informative) List of materials found acceptable or
non-acceptable for metallic combinations for nonarticulating
contacting surfaces of implants
Annex D (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives

Defines particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement. Defines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturers.