Cytotoxicity.

ISO 10993-5: MTT & MEM Elution Test

We perform MTT and MEM Elution test to evaluate the cytotoxicity potential of your Medical Devices. The MTT  test provides a quantitative measurement of cell viability, while the MEM Elution Test offers a qualitative assessment of cell viability.

Both tests are conducted on mouse fibroblast exposed to test item extracts prepared in line with ISO 10993-12, and are fully compliant with ISO 10993-5 and regulatory standards.

An ethical and accurate alternative to animal testing

Our GLP-compliant laboratories provide in vitro biocompatibility testing addressing the three endpoints that all medical devices are subjected to assess:

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Testing with SenzaGen

At a glance

Test systemL-929 CELLS.
ComplianceISO 10993-5: 2009.
What it measures QUANTITATIVE/QUALITATIVE VIABILITY OF MOUSE FIBROBLAST CELLS.
ReadoutCYTOTOXIC OR NON-CYTOTOXIC.
Turnaround time2-4 weeks for standard studies.
Fast track available.

How it works

The MTT test and the MEM Elution test are based on mouse fibroblast cells, L-929. The test item extracts, prepared according to ISO 10993-12, are applied to the L-929 cells growing as adherent cells.

The MTT test provides a quantitative measurement of cell viability by measuring the intracellular metabolism of living cells by reduction of the MTT reagent. If the relative cell viability for the highest concentration of the Test Item extract is ≥ 70 %, the material is non-cytotoxic.

The MEM Elution test provides a qualitative evaluation of cell viability by observing the cells under a microscope, assigning a cytotoxic grade (0-4) based on cell death and cell morphology. If the cytotoxic grade for the highest concentration of the Test Item extract is  ≤ 2,  (cell viability > 50 %), the material is non-cytotoxic.

  • In vitro biocompatibility testing

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