DIN EN ISO 15798:2022-05
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022); German version EN ISO 15798:2022
| Fecha edición: |
2022-05-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | The standard defines requirements with regard to the safety of ophthalmic viscoelastic substances for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labeling and the information supplied by the manufacturer and associated test methods. |
| Keywords: | Biocompatibility|Biological|Clinical investigations|Construction details|Data of the manufacturer|Definitions|Eyes|Information supplied by the manufacturer|Marking|Medical devices|Ophthalmic equipment|Ophthalmic optics|Ophthalmology|Optics|Packages|Safety|Safety requirements|Specification (approval)|Sterilization (hygiene)|Surgery|Surgical implants|Visco elastic|Viscoelastic materials|Viscosity classes |
| ICS: | 11.040.70 - Equipo oftálmico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 15798:2022 Idéntica ISO 15798:2022 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 15798:2018-02 Reemplaza a DIN EN ISO 15798:2021-02 |
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