PERFLUOROCARBON LIQUIDS (ISO 16672)
DESIGN ATTRIBUTES | METHODS |
---|---|
Chemical description and contaminants | H-Index (Annex C), GC-MS, NMR |
Refractive index | Refractometer |
Spectral Transmittance | UV-vis spectrophotometer |
Leachable substances | NMR |
DESIGN EVALUATION | METHODS |
---|---|
Evaluation of biological safety | ARPE-19 cell line, BE (2)-C cell line and neuroretina explants |
Intraocular implantation test | In-vivo models (rabbits, minipigs) |
SILICONE OILS (ISO 16672)
DESIGN ATTRIBUTES | METHODS |
---|---|
Chemical description and contaminants | NMR |
Refractive index | Refractometer |
Spectral Transmittance | UV-vis spectrophotometer |
Leachable substances | NMR |
Chemical description and contaminants | HS-GC-MS |
DESIGN EVALUATION | METHODS |
---|---|
Evaluation of biological safety | ARPE-19 cell line, BE (2)-C cell line and neuroretina explants |
Intraocular implantation test | In-vivo models (rabbits, minipigs) |
INTRAOCULAR DYES (ISO 16671)
DESIGN ATTRIBUTES | METHODS |
---|---|
pH | pHmeter |
Spectral Transmittance | UV-vis spectrophotometer |
DESIGN EVALUATION | METHODS |
---|---|
Evaluation of biological safety | ARPE-19 cell line, BE (2)-C cell line and neuroretina explants |
Evaluation of staining capacity | Ex-vivo pig eyes |
Intraocular irritation and inflammation tests | In-vivo models (rabbits, minipigs) |
OCULAR VISCOELASTIC DEVICES (OVDs) (ISO 15798)
DESIGN ATTRIBUTES | METHODS |
---|---|
pH | pHmeter |
Spectral Transmittance | UV-vis spectrophotometer |
Refractive index | Refractometer |
DESIGN EVALUATION | METHODS |
---|---|
Evaluation of biological safety | Corneal endothelial cells |
INTRAOCULAR LENS (ISO 11979)
DESIGN EVALUATION | METHODS |
---|---|
Intraocular implantation tests | Annex G In-vivo models (rabbits, minipigs) |