PERFLUOROCARBON LIQUIDS (ISO 16672)

DESIGN ATTRIBUTESMETHODS
Chemical description and contaminantsH-Index (Annex C), GC-MS, NMR
Refractive indexRefractometer
Spectral TransmittanceUV-vis spectrophotometer
Leachable substancesNMR

 

DESIGN EVALUATIONMETHODS
Evaluation of biological safetyARPE-19 cell line, BE (2)-C cell line and neuroretina explants
Intraocular implantation testIn-vivo models (rabbits, minipigs)

 

SILICONE OILS (ISO 16672)

DESIGN ATTRIBUTESMETHODS
Chemical description and contaminantsNMR
Refractive indexRefractometer
Spectral TransmittanceUV-vis spectrophotometer
Leachable substancesNMR
Chemical description and contaminantsHS-GC-MS

 

DESIGN EVALUATIONMETHODS
Evaluation of biological safetyARPE-19 cell line, BE (2)-C cell line and neuroretina explants
Intraocular implantation testIn-vivo models (rabbits, minipigs)

 

INTRAOCULAR DYES (ISO 16671)

DESIGN ATTRIBUTESMETHODS
pHpHmeter
Spectral TransmittanceUV-vis spectrophotometer

 

DESIGN EVALUATIONMETHODS
Evaluation of biological safetyARPE-19 cell line, BE (2)-C cell line and neuroretina explants
Evaluation of staining capacity Ex-vivo pig eyes
Intraocular irritation and inflammation testsIn-vivo models (rabbits, minipigs)

 

OCULAR VISCOELASTIC DEVICES (OVDs) (ISO 15798)

DESIGN ATTRIBUTESMETHODS
pHpHmeter
Spectral TransmittanceUV-vis spectrophotometer
Refractive indexRefractometer

 

DESIGN EVALUATIONMETHODS
Evaluation of biological safetyCorneal endothelial cells

 

INTRAOCULAR LENS (ISO 11979)

DESIGN EVALUATIONMETHODS
Intraocular implantation testsAnnex G      
In-vivo models (rabbits, minipigs)
Escudo de la Junta de Castilla y León
Europa impulsa nuestro crecimiento
Confinanciado por la Unión Europea