The developers of medical devices evaluate the biocompatibility of their device prior to
FDA's review and subsequent introduction to the market. Chemical characterization …

Infections associated with medical device use can have serious consequences for patients.
Such healthcare-associated infections are often challenging to treat because of the …

When equilibrium of leaching is reached within a product's duty cycle, partition coefficients
polymer/solution dictate the maximum accumulation of a leachable and thus, patient …

Toxicological risk assessment approaches are increasingly being used in lieu of animal
testing to address toxicological concerns associated with release of chemical constituents …

Medical devices often include polymeric components, which contain additives or
contaminants that may leach into patients and pose a health risk. Previously, we proposed a …

We demonstrate a novel application of the time–temperature superposition (TTS) principle to
predict solute diffusivity D in glassy polymers using atomistic molecular dynamics …

Various public health concerns can arise from the unintended leaching of additives and
impurities from polymeric medical devices or food packaging, which is directly related to …

Medical device materials contain chemicals that may pose toxicological concern (s) if
released in sufficient quantities. Toxicological risk assessment approaches are increasingly …

Extraction testing is critical for biocompatibility evaluation of medical devices, whether to
generate samples for biological testing or form the basis for toxicological risk assessment …

Biocompatibility evaluation of medical devices often relies on chemical testing according to
ISO 10993-18 as a critical component for consideration. However, the precision associated …