NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007)

Amended by

BS EN ISO 21535:2009+A1:2016

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

British Standards Institution

Foreword
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 relative angular
        motion of components
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Annex ZB (informative) - Correlations between
         undated normative references and dated
         EN and ISO standards

Gives specific requirements for hip joint replacement implants.

Committee	CH/150/4
DevelopmentNote	Supersedes BS EN 12563 & 06/30143831 DC. (10/2008) 2009 Edition Re-issued in January 2017 & incorporates AMD 1 2016. Supersedes 15/30316683 DC. (01/2017)
DocumentType	Standard
Pages	20
PublisherName	British Standards Institution
Status	Current
Supersedes	15/30316683 DC : 0 BS EN 12563:1999 BS EN ISO 21535:2007 06/30143831 DC : DRAFT JUN 2006

Standards	Relationship
EN ISO 21535:2009/A1:2016	Identical
ISO 21535:2007	Identical

ISO 7206-10:2003	Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads
ISO 14242-1:2014	Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 7206-8:1995	Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
ISO 21534:2007	Non-active surgical implants Joint replacement implants Particular requirements
ISO 7206-4:2010	Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 14242-3:2009	Implants for surgery Wear of total hip-joint prostheses Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
ISO 14242-2:2016	Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ISO 7206-6:2013	Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 14630:2012	Non-active surgical implants General requirements
ASTM F 3047M : 2015	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
EN ISO 21534:2009	Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
ISO 7206-2:2011	Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 7206-1:2008	Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)

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BS EN ISO 21535 : 2009

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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