NEN EN ISO 16672 : 2015
Current
The latest, up-to-date edition.
01-12-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical and biological contaminants
5.3 Chemical description
5.4 Concentration of the components
5.5 Density
5.6 Gaseous expansion
5.7 Interfacial tension
5.8 Kinematic viscosity
5.9 Molecular mass distribution
5.10 Particulates
5.11 Refractive index
5.12 Spectral transmittance
5.13 Surface tension
5.14 Vapour pressure
6 Design evaluation
6.1 General
6.2 Evaluation of biological safety
6.3 Clinical investigation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Clinical investigation
Bibliography
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