ANSI/AAMI/ISO 10993-16:2017
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
30-10-2020
Superseded date
13-11-2023
Superseded by
€119.17
Excluding VAT
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-778-5
|
| Pages |
20
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| 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 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| 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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