EN 12010 : 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.