NEN EN ISO 16672 : 2015

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

Applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.