Test Description
The ISO Agarose Overlay Method is a cytotoxicity test used to evaluate the biocompatibility of medical devices by assessing their potential to harm cultured cells. This method involves placing device materials on an agarose layer over cell cultures, allowing leachable substances to diffuse and interact with the cells. It is particularly useful for testing materials that do not directly contact cells and provides a sensitive, indirect measure of cytotoxicity.
Why This Test is Performed
This test helps determine whether medical device materials release toxic substances that could damage surrounding cells. It supports regulatory compliance and ensures that devices meet safety standards before clinical use. The method is especially valuable for evaluating diffusion-related cytotoxicity.
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Steps in Conducting This Test
- Preparation of Agarose: Melt 2% agarose and overlay it onto cultured cell monolayers.
- Sample Placement: Place the test material on top of the solidified agarose layer.
- Incubation: Incubate the setup at 37°C in 5% CO₂ for 24 hours.
- Evaluation: Examine the cells for morphological changes or lysis beneath the sample and extending beyond the sample. Assess cytotoxicity by observing zones of decolorization and cell lysis under a microscope.
- Scoring: Assign a cytotoxicity grade based on the size and intensity of the affected area.
Standards, Guidance, and Regulations
- ISO 10993-5: Governs in vitro cytotoxicity testing methods, including agarose overlay.
- ISO/IEC 17025: Ensures laboratory competence and test reliability.
- GLP Compliance (21 CFR Part 58): Required for regulatory submissions to ensure data integrity.
| Test Code |
|---|
| V0015-110 |
