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Biomaterials used for medical devices must be thoroughly tested according to ISO 10993 (1) before their introduction so that any negative effects on the body are known about and prevented. By using in vitro laboratory tests, dangers for patients and unnecessary animal experiments can be avoided. Here, in vitro tests for cell compatibility (cytotoxicity) and blood compatibility (haemocompatibility) are described.

Practical application

For many manufacturers and developers of medical devices, ISO 10993, Biological Evaluation of Medical Device, (1-5) is a necessary evil. However, those who are fully conversant with the different parts of the ...