I.S. EN 12010:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
Hardcopy , PDF
10-12-2007
English
01-01-1998
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 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture and inspection
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) List of materials found acceptable
for the manufacture of implants
Annex B (informative) List of 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
nonarticulating contacting surfaces of implants
Annex D (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
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