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The ability of a substance to damage cells or tissue is referred to as cytotoxicity.
The test for cytotoxicity is one of the most important test methods within the scope of the biological evaluation of medical devices (standard series DIN EN ISO 10993). The objective of this evaluation is the safety of the medical device with regard to its use in or on human beings.
The in-vitro cytotoxicity test is of special importance here, as it detects any type of cytotoxic effect of a product, without, however, specifying the exact cause.
Fibroblasts (connective tissue cells) are used for this test, as they have a high sensitivity to toxic substances. The cells are either incubated with the product itself or with an extract of the product for several days. At the end of the incubation period, the cells are microscopically examined for morphological changes and altered growth behavior, and are then dyed to quantify the number of cells. From the ratio of the number of cells coming into contact with the product to control cells, the effect of the product on the growth (proliferation) of the cells can be determined and statements made on growth inhibition by the product.
A toxic effect can be caused by the product itself (material, coating) or by residues (e.g. of cleaning agents) or contamination on the product surface. This means that positive results in the in-vitro cytotoxicity test can lead to a number of additional tests to investigate the exact cause of the cytotoxic effect.
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In-vitro cytotoxicity test (as per DIN EN ISO 10993-5)
The ability of a substance to damage cells or tissue is referred to as cytotoxicity. The test for cytotoxicity is one of the most important test methods within the scope of the biolog...
Determination of bioburden including validation (as per DIN EN ISO 1...
The objective of determination of bioburden is to determine the population of viable microorganisms (bacteria and fungi) on or in a product or its packaging. The determination of this number is...
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Endotoxin test (as per USP 85 and Ph. Eur. 2.6.14)
Endotoxins (ancient Greek endo: "inside", "within", toxins, "the poisonous substance") are part of the outer cell membrane of gram-negative bacteria, which can lead...
Hygiene in times of COVID-19 (Testing of microbiological cleanliness...
Hygiene is an important commodity at all times, but especially in the current crisis situation. Despite the fact that restrictions are beginning to be released, strict compliance with hygiene measures...
CleanControlling Medical GmbH & Co. KG
Gehrenstraße 11a
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