EN 12563 : 1998

Name: EN 12563 : 1998
Brand: CEN

Superseded

View Superseded by

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP JOINT REPLACEMENT IMPLANTS

Superseded date

01-09-2007

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 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 (normative) Evaluation of relative angular motion
         of components
Annex B (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other provisions
         of EU Directives

Defines specific requirements for hip joint replacement implants. In conjunction with safety, given also are requirements for intended performance, materials, design evaluation, design attributes, sterilization, manufacture, packaging and information supplied by the manufacturer and methods of test.

Committee	TC 285
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 21535:2009/A1:2016

Standards	Relationship
PN EN 12563 : 2004	Identical
BS EN 12563:1999	Identical
NS EN 12563 : 1ED 1998	Identical
SN EN 12563 : 1999	Identical
DIN EN 12563:1999-02	Identical
UNE-EN 12563:1999	Identical
NBN EN 12563 : 1999	Identical
I.S. EN 12563:1999	Identical
NEN EN 12563 : 1999	Identical
NF EN 12563 : 1999	Identical
UNI EN 12563 : 2000	Identical

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 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 7206-9:1994	Implants for surgery Partial and total hip joint prostheses Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
EN 12010 : 1998	NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
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 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