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AAMI/ISO 10993-5:2009 (R2014)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityMore info
The standard describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts of the device, and/or in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2014-02-06 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Replace | ANSI/AAMI/ISO 10993-5 (1999) |
| Cross references | ISO 10993-5 (2009-06), IDT |
| Year | 2009 |
| Document history | ANSI/AAMI/ISO 10993-5 (2009) |
| Country | USA |
| Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-5-2009 (R2014) |