I.S. EN ISO 16061:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
Hardcopy , PDF
English
01-01-2015
30-09-2021
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
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.
| DevelopmentNote |
Supersedes I.S. EN 12011. (02/2009)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 16061:2015 | Identical |
| EN ISO 16061:2015 | Identical |
| UNE-EN ISO 16061:2015 | Equivalent |
| BS EN ISO 16061:2015 | Equivalent |
| DIN EN ISO 16061:2015-09 | Equivalent |
A newer version of this standard is available.
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