Name: EN ISO 21535:2009/A1:2016
Brand: CEN

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007/AMD 1:2016)

Amendment of

EN ISO 21535:2009

Published date

12-07-2016

Publisher

Comite Europeen de Normalisation

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	TC 285
DevelopmentNote	Supersedes EN 12563. (10/2007)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN 12563 : 1998

Standards	Relationship
NEN EN ISO 21535 : 2009 AMD 1 2016	Identical
NF EN ISO 21535 : 2009 AMD 1 2017	Identical
ISO 21535:2007	Identical
PN EN ISO 21535 : 2009 AMD 1 2017	Identical
NS EN ISO 21535 : 2009 AMD 1 2016	Identical
I.S. EN ISO 21535:2009	Identical
SN EN ISO 21535 : 2009 AMD 1 2017	Identical
DIN EN ISO 21535 E : 2017	Identical
DIN EN ISO 21535:2009-08	Identical
NBN EN ISO 21535 : 2009	Identical
BS EN ISO 21535 : 2009	Identical
UNI EN ISO 21535 : 2009	Identical
UNE-EN ISO 21535:2009	Identical
DIN EN ISO 21535:2017-04	Identical
BS EN ISO 21535:2009+A1:2016	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)