ASTM F2459-18 is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing.
ASTM F2459-18 is suitable for determination of the total amount of extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.
ASTM F2459-18 is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).
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Keywords:Biomedical Engineering ;Chemical Composition;Extractable Residue;Gravimetric Analysis ;Gravimetry;Medical Devices
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