EN 12563 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 HIP JOINT REPLACEMENT IMPLANTS
01-09-2007
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 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.
| Committee |
TC 285
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| PN EN 12563 : 2004 | Identical |
| BS EN 12563:1999 | Identical |
| NS EN 12563 : 1ED 1998 | Identical |
| SN EN 12563 : 1999 | Identical |
| DIN EN 12563:1999-02 | Identical |
| UNE-EN 12563:1999 | Identical |
| NBN EN 12563 : 1999 | Identical |
| I.S. EN 12563:1999 | Identical |
| NEN EN 12563 : 1999 | Identical |
| NF EN 12563 : 1999 | Identical |
| UNI EN 12563 : 2000 | Identical |
| ISO 7206-8:1995 | Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion |
| ISO 7206-4:2010 | Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components |
| ISO 7206-9:1994 | Implants for surgery Partial and total hip joint prostheses Part 9: Determination of resistance to torque of head fixation of stemmed femoral components |
| EN 12010 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| ISO 7206-6:2013 | Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components |
| ISO 7206-2:2011 | Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
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