DIN EN ISO 21535:2017-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016) (includes Amendment :2016)
Hardcopy , PDF
English, German
01-04-2017
01-10-2024
National foreword
National Annex NA (informative) - Bibliography
Foreword to DIN EN ISO 21535:2017
European foreword to Amendment A1 of DIN EN ISO 21535
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 DIN EN 12563 E. (01/2008)
|
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| 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 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 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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