Cytotoxicity testing is a standard procedure used to evaluate the potential toxicity of medical devices at the cellular level. The term "cyto" refers to cells, and this type of testing examines whether a device or its materials could be “toxic” by inhibiting cell growth or even causing cell death.
By using in vitro techniques, cytotoxicity testing provides a controlled environment to study the biological response of cells. Typically, these tests are conducted on mouse fibroblast cells, which are then assessed using both qualitative and quantitative methods. The findings from these studies are then evaluated with supporting in vivo studies, ensuring reliable results before a product moves further along in development.
Why is Cytotoxicity Testing Important?
Medical devices that come into direct or indirect contact with the human body, and any toxic material could lead to adverse health effects. Cytotoxicity testing ensures that materials used in devices:
- Do not cause harm to human cells.
- Are compatible with their intended biological environment.
- Comply with regulatory requirements, such as ISO 10993-5 for biological evaluation of medical devices.
This testing is a foundational step in biocompatibility assessments, giving manufacturers the confidence that their devices meet rigorous safety standards.
Canyon Labs: Raising the Standard in Cytotoxicity Testing
At Canyon Labs, we specialize in cytotoxicity and biocompatibility testing for medical devices. Our experienced team utilizes their comprehensive expertise to deliver reliable, fast, and accurate results, helping our clients bring safe and effective devices to market.
Partner with Canyon Labs today to ensure your products meet the highest standards of biocompatibility.