BS EN ISO 21534:2009
Current
The latest, up-to-date edition.
Non-active surgical implants. Joint replacement implants. Particular requirements
Hardcopy , PDF
English
31-10-2009
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
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC
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