biocompatibility of medical devices iso 10993 - Hermon Labs
biocompatibility of medical devices iso 10993 - Hermon Labs
biocompatibility of medical devices iso 10993 - Hermon Labs
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BIOLOGICAL EVALUATION OF MEDICAL<br />
DEVICES<br />
Assessment <strong>of</strong> the biological safety <strong>of</strong> the <strong>medical</strong> device<br />
starts with:<br />
Evaluation <strong>of</strong> existing relevant data from all sources<br />
Any history <strong>of</strong> clinical use or<br />
human exposure data<br />
Any existing toxicology and<br />
other biological safety data<br />
on product and component<br />
materials, breakdown products<br />
and metabolites<br />
Identification <strong>of</strong> gaps in the<br />
available data set on the<br />
basis <strong>of</strong> a risk analysis<br />
Harlan Laboratories 10
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