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) |
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