ASTM F2459-18,Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis.ASTM F2459-18 pdf free download.
ASTM F2459-18 covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.
ASTM F2459-18 does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.
Referenced Documents
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G131 Practice for Cleaning of Materials and Components by Ultrasonic Techniques
G136 Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
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.