DIN EN ISO 10993-13:2010-11
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
| Fecha edición: |
2010-11-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | Degradation products covered by this standard are formed primarily by chemical bond scission due to hydrolytic and/or oxidative processes in an aqueous environment. It is recognized that additional biological factors, such as enzymes, other proteins and cellular activity, can alter the rate and nature of degradation. The identified and quantified degradation products form the basis for biological evaluation in accordance with ISO 10993-1, for risk assessment in accordance with ISO 10993-17 and, if appropriate, for toxicokinetic studies in accordance with ISO 10993-16. |
| Keywords: | Bioassay|Biological tests|CE marking|Decomposition|Decomposition products|Definitions|Degradability|Degradation|Deterioration|Evaluations|Identification|Medical devices|Medical products|Methods|Polymers|Quantification|Real-time|Screening-method|Specification (approval)|Testing|Verification |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-13:2010 Idéntica ISO 10993-13:2010 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-13:2009-08 Reemplaza a DIN EN ISO 10993-13:2008-08 |
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