DIN EN ISO 10993-9:2022-03
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021
| Fecha edición: |
2022-03-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of 10993 is intended to present the general principles on which the specific material investigations to identify and quantify degradation products described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys) are based. Information obtained from these studies is intended to be used in the biological evaluations described in the remaining parts of ISO 10993. |
| Keywords: | Bioassay|Biochemicals|Biodegradability|Biology|Bodies|CE marking|Decomposition products|Definitions|Degradation|Deterioration|Determination|Evaluations|Identification|In vitro|Medical devices|Medical products|Medical technology|Patients|Quantification |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-9:2021 Idéntica ISO 10993-9:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-9:2010-04 Reemplaza a DIN EN ISO 10993-9:2018-05 |
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