NF EN 12563 : 1999
Superseded
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP JOINT REPLACEMENT IMPLANTS
01-12-2013
03-01-2008
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (normative) Evaluation of relative angular motion
of components
Annex B (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives
Defines specific requirements for hip joint replacement implants. In conjunction with safety, given also are requirements for intended performance, materials, design evaluation, design attributes, sterilization, manufacture, packaging and information supplied by the manufacturer and methods of test.
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| I.S. EN 12563:1999 | Identical |
| DIN EN 12563:1999-02 | Identical |
| BS EN 12563:1999 | Identical |
| EN 12563 : 1998 | Identical |
| UNE-EN 12563:1999 | Identical |