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European Pharmaceutical Contractor

Strategies for Biocompatibility Testing of Medical Devices

Toxicity and Biocompatibility

The toxicity of a substance depends on the intrinsic properties of the material, the environment in which it is placed and the amount of the material available to exert its effect. Generally the toxicity of chemicals shows a dose-response relationship, for example for systemic toxicity and local tolerance, so that the greater the dose the greater the toxicity, but for genotoxicity it is generally accepted that a single molecule of a genotoxic substance can lead to irreversible genetic damage.

Toxicity can be seen or unseen, so for example we can observe changes in the behaviour of animals following compound administration, whereas we cannot see the changes that occur in the liver following alcohol administration. Toxicologists have therefore developed a series of tests that look at different endpoints or effects and when collectively evaluated they can give an assessment of the hazards of the material under evaluation.

The term biocompatibility is a complex term covering local tolerance, specific target toxicity (for example genetic damage) as well as systemic toxicity. The biocompatibility of a substance will depend on the chemical and material composition, shape and size. And as for toxicity, substances may be biocompatible in one environment and not in another.


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By Dr Lise Bollen, Head of Medical Device Biocompatibility Testing at Scantox AS

Dr Lise Bollen has worked for Scantox as Head of Medical Device Biocompatibility Testing since 1996. She has a Master's degree in Chemistry and Biotechnology from the University of Aarhus, Denmark and a Doctor of Medical Science degree from Uppsala University, Sweden.

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