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Biocompatibility Testing ISO 10993-5


An important part of medical device safety is to understand potential adverse effects on cells. The International Organization for Standardization 10993-5 presents several in vitro cell-based tests for understanding acute cytotoxicity of extractables from medical device materials.

Biocompatibility Testing Service Details

IONTOX follows the 10993-5 guidelines and offers a GLP and non-GLP test. Mouse or human cell lines are typically used as the test system. Cytotoxicity can be evaluated by one of three approaches. The first approach is extracting device material and then exposing cells to the extracted substances. The second approach is direct cytotoxicity testing, which can be done if the device material can be placed directly onto cells without causing damage. The final approach is indirect testing, which can be done by placing the device material onto a cushioning layer above cells. An agar overlay is often used to protect the cells from direct damage by the device. The figure below shows diagrammatically the extract test (A). Direct contact test and (B). Indirect contact test (C and D). The effects of the various test setups on cell health is evaluated qualitatively by microscopy and quantitatively by the neutral red or MTT assays. In all test cases, the use of positive and negative control is essential. The test selected is determined by the device material, and its intended use and guidelines are provided in the ISO test guidelines.

Most laboratories only use standard cell models such as the mouse L929 fibroblast cell line. While these provide a good first-tier look at cytotoxicity it may also be important to demonstrate to regulators the effects of devices on cells relevant to the device and its end-use. IONTOX will work with our clients to ensure that the most relevant set of cytotoxicity data is delivered.

Gola J. 2019. Stem Cells and Biomaterials for Regenerative Medicine. Academic Press. Chapter 10, Quality Control of Biomaterials-Overview of the Relevant Technologies; p.143-161.