ISO 10993-5:2009
Current
The latest, up-to-date edition.
Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
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English, French
20-05-2009
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ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
| DevelopmentNote |
Supersedes ISO/DIS 10993-5. (05/2009)
|
| DocumentType |
Standard
|
| Pages |
34
|
| ProductNote |
Supersedes ISO/DIS 10993-5. (Seema 05/2009)
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| GOST ISO 10993-5 : 2011 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| I.S. EN ISO 10993-5:2009 | Identical |
| PN EN ISO 10993-5 : 2009 | Identical |
| SN EN ISO 10993-5:2009 | Identical |
| UNI EN ISO 10993-5 : 2009 | Identical |
| SS-EN ISO 10993-5:2009 | Identical |
| BS EN ISO 10993-5:2009 | Identical |
| EN ISO 10993-5:2009 | Identical |
| NF EN ISO 10993-5 : 2010 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| DIN EN ISO 10993-5:2009-10 | Identical |
| ANSI/AAMI/ISO 10993-5:2009(R2022) | Identical |
| SAC GB/T 16886.5:2017 | Identical |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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