Cytotoxicity Study Using the MEM Elution Method

The cytotoxicity ISO MEM elution method evaluates the potential toxicity of medical devices by assessing the effects of eluates (extracts) from the device materials on cultured cells grown in Minimum Essential Medium (MEM). This test determines whether harmful substances leach from the device and cause adverse effects on cell viability, proliferation, or morphology, ensuring patient safety and biocompatibility.

Why This Assessment is Performed

Cytotoxicity MEM elution method testing is performed to ensure that medical devices do not release harmful substances that could negatively impact living cells. This testing helps identify any toxic leachables present in the device materials, ensuring that the device is safe for use in medical applications.

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Steps in Conducting This Test

1. Sample Preparation: Prepare samples of the medical device material for extraction.
2. Extraction: Extract the device material using a suitable solvent to obtain eluates.
3. Cell Culture: Culture appropriate cell lines, such as fibroblasts or epithelial cells, in Minimum Essential Medium (MEM).
4. Eluate Exposure: Expose the cultured cells to the eluates for a specified period, typically 24-72 hours.
5. Evaluation: Assess cell viability, proliferation, and morphology using methods such as the MTT assay, neutral red uptake, or microscopic examination.
6. Interpretation: Compare the test results to control samples to determine if the eluates are cytotoxic.

Standards, Guidance, and Regulations

When conducting cytotoxicity ISO MEM elution method testing for medical devices, it is essential to follow specific standards and guidelines:

• ISO 10993-5: This international standard provides guidelines for in vitro cytotoxicity testing of medical devices, including the MEM elution method.
• ASTM Standards: Various ASTM standards provide detailed instructions for conducting cytotoxicity tests on medical devices.
• FDA Guidance: The U.S. Food and Drug Administration (FDA) provides specific guidance on conducting cytotoxicity testing for medical devices within the FDA Guidance to Industry – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.