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I.S. EN ISO 21534:2009

Current
Current

The latest, up-to-date edition.

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
   5.1 General
   5.2 Surface finish of metallic or ceramic implants articulating
        on ultra-high-molecular-weight polyethylene (UHMWPE)
   5.3 Surface finish of metallic or ceramic partial implants
   5.4 Surfaces of convex, spherically-conforming metallic or
        ceramic implants articulating on UHMWPE
   5.5 Surfaces of spherically-conforming metallic or ceramic
        partial implants
   5.6 Surfaces of concave, spherically-conforming UHMWPE
        components
6 Materials
   6.1 General
   6.2 Dissimilar metals or alloys
7 Design evaluation
   7.1 General
   7.2 Preclinical evaluation
   7.3 Clinical investigation
   7.4 Post market surveillance
8 Manufacture and inspection
   8.1 General
   8.2 Metal surfaces
   8.3 Plastic surfaces
   8.4 Ceramic surfaces
9 Sterilization
   9.1 General
   9.2 Expiry
10 Packaging
11 Information supplied by the manufacturer
   11.1 General
   11.2 Labelling of implants for use on one side of the
        body only
   11.3 Instructions for orientation of implants
   11.4 Markings for orientation of the implants
   11.5 Placing of markings on implants
   11.6 Restrictions on use
   11.7 Re-sterilization of zirconia ceramics
   11.8 Labelling of implants for use with or without bone cement
Annex A (informative) List of International Standards for materials
        found acceptable for the manufacture of implants
Annex B (informative) List of International Standards for materials
        found acceptable or not acceptable for articulating
        surfaces of implants
Annex C (informative) List of materials found acceptable or
        non-acceptable for metallic combinations for
        non-articulating contacting surfaces of implants
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Describes particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants.

DevelopmentNote
Supersedes I.S. EN 12010. (10/2007)
DocumentType
Standard
Pages
28
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 21534:2009 Identical
ISO 21534:2007 Identical

BS 6324-3:1983 Terms relating to surgical implants Glossary of terms relating to materials
BS 6324-2:1983 Terms relating to surgical implants Glossary of terms relating to mechanics
ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
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
ASTM F 1357 : 2014 : REDLINE Standard Specification for Articulating Total Wrist Implants
BS 6324-5:1990 Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery
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 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ASTM F 370 : 1994 : R1999 Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
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/TR 9326:1989 Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces
ISO/TR 9325:1989 Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses
ISO 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
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
BS 6324-1:1983 Terms relating to surgical implants Glossary of general medical terms
ISO 9583:1993 Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants
ASTM F 1223 : 2014 : REDLINE Standard Test Method for Determination of Total Knee Replacement Constraint
ISO 14879-1:2000 Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays
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 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implants
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 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
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
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
BS 6324-4:1983 Terms relating to surgical implants Glossary of orthopaedic surgical terms
NFS 94 065 : 1998 MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM

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