Cytotoxicity testing

DIN EN ISO 10993-5:2009

This test is used to assess cytotoxicity for medical devices which have contact with human skin. L929 fibroblasts are exposed to different concentrations (e.g. 10%, 30%, 50%, 70% and 100%) of an extract of a medical device for 24 hours. After exposure, fibroblast morphology is evaluated (Prediction 1) and viability is assessed using the MTT test (colorimetric assay). If remaining viability is >70% the medical device is not cytotoxic (Prediction 2).

Prediction Model 1

Morphology Reactivity Grading
discrete intracytoplasmic granule; no cellular dissolution; no inhibition of growth none 0
not more than 20% of cells are round, loosely attached and without any intracytoplasmic granule or show changes in morphology; a few dissolved cells are present, only slight growth inhibition is noticeable slight 1
not more than 50% of cells are round; free of intracytoplasmic granule; no extensive cell dissolution is detected; not more than 50% growth inhibition noticeable mild 2
not more than 70% of cell layers contain round or dissolute cells; layers are not completely destroyed, but more than 50% growth inhibition is noticeable moderate 3
almost complete or complete destruction of cell layers severe 4

Prediction Model 2

Percentage of cell viability Prediction
100 – 70% Not cytotoxic
70 – 50% Weakly cytotoxic
50 – 30% Moderately cytotoxic
30 – 0% Severely cytotoxic

If viability is reduced to < 70% of the blank, the test item has cytotoxic potential.


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