BS EN ISO 10993-16:2017
Current
Current
The latest, up-to-date edition.
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
30-03-2020
Publisher
€249.79
Excluding VAT
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes 96/560211 DC. (11/2005) Supersedes 08/30187781 DC. (03/2010) Supersedes 16/30335531 DC. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
28
|
| ProductNote |
Annexes ZA and ZB added
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. AnnexA describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
| Standards | Relationship |
| DIN EN ISO 10993-16:2016-04 (Draft) | Identical |
| NBN EN ISO 10993-16 : 2010 | Identical |
| I.S. EN ISO 10993-16:2010 | Identical |
| ISO 10993-16:2017 | Identical |
| EN ISO 10993-16:2017 | Identical |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices — Part 22: Guidance on nanomaterials |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| 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 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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