What is ISO 10993 5?
ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
What is in vitro cytotoxicity?
The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices.
How do you test for cytotoxicity?
The cytotoxicity test is designed to evaluate the general toxicity of medical devices and materials. Testing involves extracting devices in a cell culture media and then exposing the extract fluid to mouse fibroblast cells (L929).
How long does sensitization testing take?
TEST METHODS Guinea pig sensitization tests require six to eight weeks and thus take the longest time to complete of all the acute biocompatibility tests described in the 10993 standards.
What does Trypan Blue do?
Trypan blue is a cell impermeant stain used to estimate the number of dead cells in a viable population. Its utility is based on the fact that it is a charged dye and does not enter cells unless the membrane is compromised.
What is the difference between cytotoxicity and toxicity?
Whilst toxicity is a more general term for how harmful a substance is to an organism; cytotoxicity is the term for how toxic a substance is to cells. A cytotoxic compound can cause cell damage or death, either through necrosis or apoptosis.
How many types of cytotoxicity is there?
There are three types of cytotoxicity tests: extract, direct contact and indirect contact. The nature of the sample and its intended use will determine which test is most appropriate.
What is cytotoxic food testing?
Cytotoxic tests (“Bryan’s test”) are based on observing changes to white blood cells after exposing them to potential allergens, while the antigen leucocyte cellular antibody test (ALCAT) measures changes in the white blood cell diameter after being challenged with specific food substances to detect intolerances.
What is Sensitisation testing?
The Sensitization test is used for the determination of sensitizing activity of chemicals and medical devices. These tests are assessing the potential of a material or product to cause a delayed hyper-sensitivity reaction.