BS EN ISO 10993-5:2009
Superseded
Biological evaluation of medical devices Tests for in vitro cytotoxicity
Hardcopy , PDF
English
07-31-2009
04-07-2025
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes BS EN 30993-5 & 97/563755 DC. (05/2005) Supersedes 07/30160957 DC. (07/2009)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| Supersedes |
This part of ISO10993 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.
| Standards | Relationship |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NF EN ISO 10993-5 : 2010 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| I.S. EN ISO 10993-5:2009 | Identical |
| DIN EN ISO 10993-5:2009-10 | Identical |
| EN ISO 10993-5:2009 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| ISO 10993-5:2009 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| BS 6155:1990 | Specification for tracheal tubes for large animals in veterinary anaesthesia |
| 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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