Codes et normes - Achat
CAN/CSA-ISO 10993-5-01
Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity (Adopted ISO 10993-5:1999, second editon, 1999-05-15)
SKU: 2415349
Publié par CSA Group
Année de publication 2001
8 pages
Withdrawn
détails du produit
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.
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.