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Norm
ÖNORM EN ISO 10993-16
Issue date: 2018 01 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of tox...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 25 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 10993-16
2018 01 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
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ÖNORM EN ISO 10993-16
2010 06 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
ÖNORM EN ISO 10993-16
2009 09 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
ÖNORM EN ISO 10993-16
1998 03 01
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
