Analyse chemical composition that may have been introduced to the medical devices during the manufacturing, packaging, shipping, and routine sterilisation process. This includes their potential as extractables and leachables that may impose serious adverse effects to the patients upon direct contact.
The study of the medical devices' physical performance characteristics under varying environmental conditions. Physical evaluation is a part of the early stages of the medical devices testing in advance to biocompatibility.
Product safety tests for medical devices that look at the human body's biological effect resulting from the direct contact with the devices' materials. Complete range of the biological evaluation testings for medical devices are mandated in ISO 10993. Additional tests for evaluating the devices' performance from the biological/microbiological perspectives are also available.
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