DIN EN ISO 10993-5:2009-10
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
| Fecha edición: |
2009-10-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This standard describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or trough diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. |
| Keywords: | Bioassay|Biological analysis and testing|CE marking|Culture media|Cytotoxicity|Definitions|Dental equipment|Dental instruments|Implants (surgical)|In vitro|In-vitro diagnostic|Medical devices|Medical equipment|Medical products|Medical sciences|Surgical equipment|Surgical implants|Test methods|Test procedures|Testing |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-5:2009/A11:2025 Idéntica ISO 10993-5:2009 |
|
Modificaciones Normas |
Es modificada por DIN EN ISO 10993-5/A11:2025-05 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-5:1999-11 Reemplaza a DIN EN ISO 10993-5:2007-06 |
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