ISO 10993-5 Biological Evaluation of Medical Devices – Standard Practice for In Vitro Cytotoxicity Testing

Cytotoxicity is defined as the extent to which a test item causes damage (toxicity) to cells. This can occur by one or more mechanisms, including decreased metabolic capacity or damage to cell membranes.

The test described here is an extract method for the quantitative assessment of cytotoxicity by metabolic capacity (MTT test) or membrane damage (Neutral Red Uptake – NRU). A sterile sample of the test substance is incubated with a solvent for 24 hours, then the solvent containing the extracts from the sample is tested.

The method provides percent viability values ​​relative to untreated controls and an EC50 value (EC50 is the concentration of the test element required to reduce the viability of cells to 50%). Methods for determining qualitative cytotoxicity by direct or indirect contact are also available; these are accomplished by applying the test item directly to a cell layer or an agar layer located on the cell surface.

The method uses human dermal fibroblasts in animal product-free culture conditions. This test system provides the advantages of using a fully human cell-based system to predict human toxicity with maximum relevance to human physiology. The test item is prepared in cell culture medium. The test item is serially diluted to 12 test concentrations and three replicates of each concentration are tested.

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