DIN EN ISO 10993-3:2015-02
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 / Note: To be replaced by DIN EN ISO 10993-3 (2025-05).
| Fecha edición: |
2015-02-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: - genotoxicity, - carcinogenicity and - reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. |
| Keywords: | Bioassay|Biological|Biological hazards|Biological tests|Carcinogenic materials|Carcinogens|CE marking|Definitions|Dental equipment|Dental instruments|Dental materials|Evaluations|Fine mechanics|Genes|Genetics|Genotoxicity|Implants (surgical)|In vitro|In vivo|Materials|Medical devices|Medical equipment|Medical sciences|Methods|Preparation|Reproductions|Reproductive system|Sample preparation|Samples|Surgical equipment|Surgical implants|Testing|Toxicity |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-3:2014 Idéntica ISO 10993-3:2014 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-3:2009-08 Reemplaza a DIN EN ISO 10993-3:2013-03 |










