I.S. EN 12011:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
Hardcopy , PDF
English
01-01-1998
02-02-2009
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
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
Defines general requirements for instruments to be used in association with non-active surgical implants.
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 12011 : 1998 | Identical |
| NEN EN 12011 : 1998 | Identical |
| NBN EN 12011 : 1998 | Identical |
| NS EN 12011 : 1ED 1998 | Identical |
| EN 12011 : 1998 | Identical |
| BS EN 12011:1998 | Identical |
| DIN EN 12011:1998-03 | Identical |
| UNE-EN 12011:1998 | Identical |
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