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.
Dates of withdrawal of national standards are available from NSAI.
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
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