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immediate downloadReleased: 2020-03-30
BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
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| Standard number: | BS EN ISO 10993-16:2017 |
| Pages: | 28 |
| Released: | 2020-03-30 |
| ISBN: | 978 0 539 13460 5 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 10993-16:2017
This standard BS EN ISO 10993-16:2017 Biological evaluation of medical devices is classified in these ICS categories:
- 11.100.20 Biological evaluation of medical devices
This document 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.