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BSI
BS EN ISO 21536 : 2009

BS EN ISO 21536 : 2009

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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

British Standards Institution

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.

Committee
CH/150/4
DevelopmentNote
Supersedes 06/30143888 DC and BS EN 12564. (09/2008) 2009 Edition Re-Issued in April 2014 & incorporates AMD 1 2014. Supersedes 12/30258387 DC. (04/2014)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
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 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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Hardcopy - English
PDF - English
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