I.S. EN ISO 16671:2015&A1:2017
Current
The latest, up-to-date edition.
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
Hardcopy , PDF
English
12-10-2017
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
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Packaging
10 Information supplied by the manufacturer
Annex A (informative) Example of a suitable method for pH measurement and buffer capacity determination
Annex B (normative) Particulate contamination: Visible particulates
Annex C (informative) Light obscuration test method for particulate contamination: subvisible particles
Annex D (informative) Microscopic test method for particulate contamination: subvisible particles
Annex E (normative) Intraocular irrigation test
Annex F (informative) Clinical investigation
Bibliography
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