ASTM F 2459 : 2024 : REDLINE

1.1This test method covers the quantitative assessment of the amount of residue obtained from metallic, polymeric, and ceramic medical components when extracted with aqueous or organic solvents.

1.2This test method does not advocate an acceptable level of cleanliness. It identifies two possible techniques to quantify extractable residue on metallic, polymeric, and ceramic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Other extraction techniques that are considered exhaustive for surface residuals could also be used if validated to ensure the required extraction efficiency.

1.3Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods.

1.4The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the suitability for a specific medical component should be demonstrated by validation or study. See Appendix X2.

1.5This test method 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, that is, does not intend to satisfy the extractables and leachables requirement of ISO 10993-18. In addition, this document does not apply to the following medical devices:

1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7This standard may involve hazardous or environmentally restricted materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.