I.S. EN ISO 21535:2009
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007)
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and 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 (informative) - Evaluation of relative angular motion
of components
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements of
EU Directive 93/42/EEC
Annex ZB (informative) - Correlations between undated
normative references and dated EN and ISO
standards
Gives specific requirements for hip joint replacement implants.
| DevelopmentNote |
Supersedes I.S. EN 12563. (10/2007)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 21535:2007 | Identical |
| ISO 7206-10:2003 | Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads |
| ISO 14242-1:2014 | Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
| 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 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| 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 14242-3:2009 | Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test |
| ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
| 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/TR 9326:1989 | Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces |
| ISO/TR 9325:1989 | Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ASTM F 3047M : 2015 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
| 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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