Cytotoxicity
Cytotoxicity is the most common test category utilized in ensuring the safety of medical devices. Used as an important screening tool as well as a significant biological endpoint for submission requirements, these tests assess the cytotoxic potential of a device or material to inhibit cell growth or cause cell death. These in vitro assays can be performed in both qualitative and quantitative methods. The appropriate test method is selected based on the nature of the sample to be evaluated, the potential site of use and the nature of use.
Eurofins Medical Device Testing network of laboratories has more than 30 years of experience in performing biological safety testing of medical devices.
Choose Eurofins Medical Device Testing to help you:
- Understand testing and the regulatory requirements for Cytotoxicity
- Screen raw materials
- Select the right test method for your device according to ISO 10993-5/USP <87> or combination of them both
- Identify cytotoxic effects of potential leachables from your product
Regulatory
- ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity" provides the general requirements for evaluating the cytotoxic potential of a medical device.
- ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”
Qualitative Evaluation Methods
- MEM Elution Assay
- Direct Cell Contact Test
- Agarose Overlay
- Agar Diffusion Test
- Colony Formation Assay
Quantitative Evaluation Methods
- XTT Staining
- MTT Staining
- Neutral Red Uptake (NRU) Staining
- BCA Assay
