I.S. EN ISO 21536:2009
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007)
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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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 range of relative
angular motion of components of fully constrained
total knee joint replacement implants
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
Gives specific requirements for knee joint replacement implants.
| DevelopmentNote |
Supersedes I.S. EN 12564. (10/2007)
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 21536:2007 | Identical |
| ISO 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 7207-2:2011 | Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
| ISO 14879-1:2000 | Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays |
| ISO 7207-1:2007 | Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions |
| ISO 14243-3:2014 | Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test |
| ISO 14243-1:2009 | Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test |
| ISO 14243-2:2016 | Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
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