BS EN ISO 16061:2015
Superseded
View Superseded by
Instrumentation for use in association with non-active surgical implants. General requirements
Hardcopy , PDF
English
05-31-2015
04-06-2021
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Selection of materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - Examples of typical
instrument applications, together with
materials found acceptable for instrument
manufacture
Bibliography
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on
medical devices
Defines general requirements for instruments to be used in association with non-active surgical implants.
| Committee |
CH/150
|
| DevelopmentNote |
Supersedes BS EN 12011. (06/2009) Supersedes 13/30285624 DC. (05/2015)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 16061:2015 | Identical |
| EN ISO 16061:2015 | Identical |
| DIN EN ISO 16061:2015-09 | Equivalent |
| I.S. EN ISO 16061:2015 | Equivalent |
| UNE-EN ISO 16061:2015 | Equivalent |
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