ANSI/AAMI/ISO 10993-16:2020(R2022)
Current
Current
The latest, up-to-date edition.
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
09-10-2023
€123.33
Excluding VAT
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-778-5
|
| Pages |
20
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-16:2017 | Identical |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices — Part 22: Guidance on nanomaterials |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process |
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