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sklademVydáno: 2017
ISO 10993-16:2017
ISO 10993-16:2017-Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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Anglicky PDF
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Anglicky Hardcopy
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Francouzsky Hardcopy
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| Označení normy: | ISO 10993-16:2017 |
| Počet stran: | 13 |
| Vydání: | 3 |
| Vydáno: | 2017 |
DESCRIPTION
ISO 10993-16:2017
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.