Name: DIN EN ISO 21535:2009-08
Brand: DIN

DIN EN ISO 21535:2009-08

Superseded

NICHTAKTIVE CHIRURGISCHE IMPLANTATE - IMPLANTATE ZUM GELENKERSATZ - BESONDERE ANFORDERUNGEN AN IMPLANTATE FUER DEN HUEFTGELENKERSATZ (ISO 21535:2007 + AMD 1:2016)

Available format(s)

Hardcopy , PDF

Superseded date

03-07-2021

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Foreword to DIN EN ISO 21535:2017
European foreword to Amendment A1 of DIN EN ISO 21535
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 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.

DevelopmentNote	Supersedes DIN EN 12563. (12/2007)
DocumentType	Standard
Pages	17
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
Supersedes	DIN EN 12563:1999-02

Standards	Relationship
ISO 21535:2007	Identical
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 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
DIN EN ISO 14630:2013-03	Non-active surgical implants - General requirements (ISO 14630:2012)
ASTM F 3047M : 2015	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
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
DIN EN ISO 21534:2009-08	NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS