ASTM F2459-18 is a standard for the removal and measurement of residues from the surface of metallic medical components. Usually the purpose of this standard is to determine the amount of oils, greases, protective coatings and other residues that can adhere to the surface of metallic medical components during production or processing.

Such surface debris can adversely affect the performance, biocompatibility and overall safety of medical devices. For example, surface debris may impair the desired biological response of the device or prevent the implant from being properly integrated. Therefore, effective measurement and control of surface debris is critical to the safe and effective use of medical devices.

The ASTM F2459-18 standard typically provides specific test methods and protocols for measuring surface residues. Surface residues are usually removed using suitable solvents and/or detergents. The amount of residue removed is then quantified using analytical techniques. These techniques may include gravimetric analysis, spectroscopic analysis or chromatographic techniques.

Such testing may be included in quality control and quality assurance programs as part of the manufacturing process of metallic medical components. In addition, these tests are often required for a medical device to meet regulatory requirements before it is released.

ASTM F2459-18 is an important standard for surface cleanliness of metallic medical components and is often used in conjunction with other biocompatibility tests such as ISO 10993.