I.S. EN ISO 16061:2021
Current
The latest, up-to-date edition.
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Hardcopy , PDF
English
18-04-2021
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.
Foreword
Introduction
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 applications of instruments to be used in association with non-active surgical implants and materials found acceptable for instrument manufacture
Bibliography
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