DIN EN ISO 11979-5:2021-05
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020); German version EN ISO 11979-5:2020
| Fecha edición: |
2021-05-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies particular requirements for the biological evaluation of intraocular lenses, which apply in addition to the general requirements set forth in the horizontal standards for medical devices. The project further gives guidance on ocular implantation tests. |
| Keywords: | Bioassay|Biocompatibility|Biological tests|Chemical properties|Evaluations|Eyepieces|Genotoxicity|Implantation test|Impurities|Intraocular lenses|Lenses|Medical devices|Medical products|Ophthalmic optics|Ophthalmology|Optical instruments|Optics|Physical properties|Physico-chemical methods|Resistance|Specification (approval)|Surgical implants|Testing|Toxicity |
| ICS: | 11.040.70 - Equipo oftálmico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11979-5:2020 Idéntica ISO 11979-5:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11979-5:2010-11 Reemplaza a DIN EN ISO 11979-5:2019-06 |
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