Genotoxicity
ISO 10993-3 genetic toxicology of device extracts: bacterial reverse mutation (Ames), chromosomal aberration, and mouse lymphoma (TK). These are three methods, not one panel, unless the evaluation says otherwise.
Genotoxicity is a battery, not a testISO 10993-3 expects both a bacterial and a mammalian-cell assay; a negative Ames alone does not close the endpoint. It is also the endpoint most often addressed by chemical characterization and a toxicological risk assessment instead — except in China, where a chemistry-first substitution is not accepted.
Genotoxicity: Bacterial Reverse Mutation Assay (AMES), 2 Extracts (GLP) - Internationally Sourced
The Ames assay asks whether an extract of your device causes gene mutation in bacteria.
GRK-4005-01X
Genotoxicity: Chromosomal Aberration Assay, 2 Extracts (GLP) - Internationally Sourced
The chromosomal aberration assay asks whether your device’s extractables break or rearrange chromosomes.
GRK-4005-02X
Genotoxicity: Mouse Lymphoma Assay (TK Assay), 2 Extracts (GLP) - Internationally Sourced
The mouse lymphoma assay asks whether your device’s extractables cause mutation in mammalian cells.
GRK-4005-03X
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