AS ISO 10993.5:2002
$33.80
Biological evaluation of medical devices – Tests for in vitro cytotoxicity
| Published By | Publication Date | Number of Pages |
| AS | 2002-06-28 | 16 |
Specifies requirements for test methods to assess the in vitro cytotoxicity for biological evaluation of medical devices.
Scope
This part of ISO 10993 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
a) with extracts of a device, and/or
b) in contact with a device.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
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