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UNE EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Evaluación biológica de productos sanitarios. Parte 16: Diseño del estudio toxicocinético de productos de degradación y sustancias lixiviables. (ISO 10993-16:2017).
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| Standard number: | UNE EN ISO 10993-16:2018 |
| Pages: | 27 |
| Released: | 2018-05-16 |
| Status: | Standard |
DESCRIPTION
UNE EN ISO 10993-16:2018
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.