NEN EN ISO 16671 : 2015 AMD 1 2017
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
01-12-2013
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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