Cytotoxicity
Cytotoxicity is a rapid, standardized test that is very sensitive and is an inexpensive way to determine if the materials in that of a medical device contain significant quantities of harmful extractables and their effect on cellular components. Required for all types of medical devices. Cellular toxicity is covered in ISO 10993-5. For agar overlay media is placed on top of a monolayer of L-929 cells, and a sample is placed on top of the agar media then incubated. For MEM elution the sample is place in contact with the monolayer of L-929 cells and then incubated. In both methods the cells are scored for cytopathic effect.
Optional Tests for Cytotoxicity
MEM Elution and pH for gloves ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
Other cell lines ISO 10993-5, USP 87
Direct cell contact ISO 10993-5, USP 87
This test is designed to determine the cytotoxicity of a substance, as evidenced by cellular effects or cytotoxicity, employing direct cell contact of the test sample. This procedure allows for simultaneous extraction and testing of leachable chemicals from the specimen with a serum-supplemented medium. It is not appropriate for very low or high-density materials that could cause mechanical damage to the cells.
MEM elution, titration, 4 dose levels, L929 ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
MEM elution, 3 extracts, triplicate, L929 cells ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
MEM elution cell culture assay 72 hr. incubation, triplicate, L929 cells ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
MEM elution cell culture assay 48 hr. incubation, triplicate, L929 cells ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
Agar overlay cell culture assay ISO 10993-5, USP 87
Samples are tested for cytotoxic effect. A cell culture media (agar) is placed on top of a monolayer of L929 cells. The sample is placed on top of the agar media and the cells are incubated. The cells are then scored for cytotoxic effect.
