DIN EN ISO 21536:2014-07
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014) (includes Amendment :2014)
Hardcopy , PDF
German, English
01-07-2014
01-10-2024
National foreword
National Annex NA (informative) - Bibliography
Foreword to EN ISO 21536:2009
Foreword to EN ISO 21536:2009/A1:2014
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
Defines requirements for knee joint replacement implants.
| DevelopmentNote |
Supersedes DIN EN 12564. (12/2007)
|
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| 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 |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| 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 |
| DIN EN ISO 21534:2009-08 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
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