I.S. EN ISO 21534:2009
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
Hardcopy , PDF
English
01-01-2009
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.
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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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