Name: DIN EN ISO 21536 E : 2014
Brand: DIN

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)

Published date

01-12-2013

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.

DevelopmentNote	Supersedes DIN EN 12564 E. (01/2008)
DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

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
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 E : 2009	NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS