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Cytotoxicity testing is used to determine the toxicity of medical devices and materials. Cytotoxicity testing evaluates whether a material can affect living cells. Medical Device Manufacturers are required to show that their devices are not cytotoxic.

Biocompatibility is defined as “The ability of a device material to perform with an appropriate host response in a specific situation”.

ISO 10993-18 focus on chemical characterisation of medical device material within a risk management process. Part of this process is the identification, quantification of extractables and leachable compounds using gas chromatography/mass spectrometry (GC/MS) technology.

GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.

The Fourier Transforms converts the raw data from the infrared emission into a spectrum which Medistri’s laboratory uses to study, analyse and identify the compound.

At Medistri, we believe our focus on using our resources to create sustainable solutions are both ambitious and necessary.

We've popularised & offered a smarter alternative to the market called the “ Biological Indicator/ Bioburden Approach”.