DIN EN ISO 10993-16:2025-12
Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025); German and English version prEN ISO 10993-16:2025 / Note: Date of issue 2025-11-21*Intended as replacement for DIN EN ISO 10993-16 (2018-02).
| Fecha edición: |
2025-12-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices and provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. |
| Keywords: | Basis|Bioassay|Biological|Biological hazards|Biological tests|Definitions|Degradability|Degradation|Design|Determination|Distribution|Evaluations|Experimental design|Experimental set-up|Extracts|Guide books|Half-life|Information|Investigations|Medical devices|Medical equipment|Medical products|Metabolism|Methods|Organisms|Precipitation|Products|Test performance|Testing|Toxicity|Toxicokinetic|Toxicological|Toxicological testing|Toxicology |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: |
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