ISO 10993-5: In Vitro Tests for Cytotoxicity
Zymetrix conducts in vitro tests in fulfillment of the requirements of ISO 10993-5 for cytotoxicity. Zymetrix can perform qualitative assessment techniques using cytochemical stains which entails examining the cells microscopically and assess changes in general morphology, vacuolization, detachment, cell lysis and membrane integrity. Examples of tests that can incorporate qualitative assessment include extract testing, direct contact testing, indirect contact testing, and filter diffusion testing. Zymetrix also performs quantitative assessment techniques which entails staining the cells with either MTT or XTT and then reading with spectrophotometer at the relevant wavelength. From comparing to a negative control, we can assess the impact of the biomaterial on the health of the cells. This can be performed in the direct contact testing and extract testing techniques.
- Annex A: NRU test
- Annex C: MTT test
- Annex D: XTT test