EN ISO 21534:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and 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 International Standards for
        materials found acceptable for the manufacture of
        implants
Annex B (informative) - List of International Standards for
        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
        non-articulating contacting surfaces of implants
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements
         of EU Directive 93/42/EEC
Bibliography

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.