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    Toxicity Risk Assessment

Toxicity Risk Assessment of Combination Devices and Medical Devices

A toxicological Risk Assessment is one step after the gathering the chemical information about a medical device in order to prove its biocompatibility proprieties.

The Safety of a medical device is evaluated by in vivo and in vitro studies. These studies are performed to simulate the clinical use conditions and worse scenario conditions of use of a medical device using different extraction solvents and analytical techniques.

Once the data is generated and reported in ug/device the materials identified and quantified are further analysed by toxicologists to evaluate their safety or any concerned addressed. The concentration of these materials is further converted taking into consideration Uncertainty Factors and compared with Margin of Safety (MOS). If the value of the materials present and released from the device during the extractions is <MOS further concerns have to be addressed, while when this value is >MOS it is deemed for the device to raise no toxicological concerns. The latter is performed using comprehensive databases where the information about the toxicity of those substances is well evaluated.

The TRA is a conservative approach in addressing the safety of a medical device, where the materials of construction, intended use, interaction between the device and potential drugs or fluids, patient group and cumulative use of the device must be addressed.

At medical engineering technologies we offer a broad range of information gathering techniques including Extractables and Leachable studies, Degradation studies, Residual cleaning for direct contact medical devices as well as testing according to ISO18562 for gas pathway medical devices including Volatile Organic Compounds, particulate emissions and Leachable in condensate analysis followed by Toxicological Risk assessment.

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