NEN EN 12564 : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS
08-10-2007
12-01-2013
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 range of relative angular motion
of components of fully constrained total knee joint
replacement implants
Annex B (normative) Bibliography
Annex ZA (informative) Clauses of this European Standard addressing
essential requirements or other provisions of EU Directives
Defines specific requirements for knee joint replacement implants. Conforming to safety, gives requirements for intended performance, manufacture, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| UNE-EN 12564:1999 | Identical |
| DIN EN 12564:1999-02 | Identical |
| BS EN 12564:1999 | Identical |
| I.S. EN 12564:1999 | Identical |
| EN 12564 : 1998 | Identical |
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