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 />
Identification <strong>of</strong> additional data<br />
necessary to analyze the biological<br />
safety <strong>of</strong> the device<br />
The physical and chemical<br />
characteristics <strong>of</strong> the various<br />
candidate materials<br />
In assessing the relevance <strong>of</strong><br />
data, on prior use <strong>of</strong> a material,<br />
to the biological evaluation,<br />
the level <strong>of</strong> confidence in<br />
the historical data should be<br />
taken into account<br />
Harlan Laboratories 11
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