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Medical device chemical characterization Medical device material chemical characterization, which refers to the qualitative versus quantitative study of the identification of a material and the chemicals present in the material or finished medical device, understanding the physicochemical characteristics of the device surface, the precipitation characteristics of chemical components, and thus determining whether the risk of device biocompatibility is acceptable, is an important approach in the evaluation of the biocompatibility of medical devices. Material equivalence studies: for material class related changes, some compliance testing or assessment of the material itself Composition analysis: heavy metal residue, elemental composition analysis and additive / auxiliary composition analysis Physicochemical tests: GB / t14233.1chemical project test, molecular weight size and distribution, optical rotation and intrinsic viscosity, etc Examination of properties: physicochemical, physico-mechanical, corrosion and aging properties, etc Leachables and leachables study: chemical contaminants, leachables and leachables study of the production process Toxicological risk assessment: tolerable exposure level, derivation of tolerable intake, exposure assessment as well as risk determination, etc
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