DIN EN ISO 9394:2013-01
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012); German version EN ISO 9394:2012
| Fecha edición: |
2013-01-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | The document specifies an in-vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test is described in application to rabbit eyes. |
| Keywords: | Aid to vision|Bioassay|Biocompatibility|Biological analysis and testing|Biological tests|Compatibility|Contact lenses|Determination|Evaluations|Experimental animals|In vivo|Materials|Medical devices|Medical products|Microbiology|Ophthalmic optics|Optics|Preservative agents|Rabbits|Safety|Specification (approval)|Testing |
| ICS: | 11.040.70 - Equipo oftálmico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 9394:2012 Idéntica ISO 9394:2012 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 9394:1998-11 Reemplaza a DIN EN ISO 9394:2011-10 |
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