DIN EN ISO 21536 E : 2014
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)
12-01-2013
National foreword<br>National Annex NA (informative) - Bibliography<br>Foreword to EN ISO 21536:2009<br>Foreword to EN ISO 21536:2009/A1:2014<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Intended performance<br>5 Design attributes<br>6 Materials<br>7 Design evaluation<br>8 Manufacture<br>9 Sterilization<br>10 Packaging<br>11 Information to be supplied by<br> the manufacturer<br>Annex A (informative) - Evaluation of range of<br> relative angular motion of components of fully<br> constrained total knee joint replacement implants<br>Annex ZA (informative) - Relationship between this<br> European Standard and the Essential Requirements<br> of EU Directive 93/42/EEC on medical devices
Defines requirements for knee joint replacement implants.
| DevelopmentNote |
Supersedes DIN EN 12564 E. (01/2008)
|
| DocumentType |
Standard
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| 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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