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DIN EN ISO 21536:2014-07

DIN EN ISO 21536:2014-07

Current

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)

Available format(s)

Hardcopy , PDF

Language(s)

German

Published date

07-01-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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.

Committee
TC 150
DevelopmentNote
Supersedes DIN EN 12564. (12/2007)
DocumentType
Standard
Pages
13
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

Standards Relationship
EN ISO 21536:2009/A1:2014 Identical
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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Hardcopy - German
PDF - German
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