UNI EN 12011 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
16-04-2009
01-01-2000
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 supplied by the manufacturer
Annex A (informative) Bibliography
Annex B (informative) A listing of some of the materials
found acceptable for instrument manufacture together with
typical applications
Annex C (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
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