ASTM Activities for Assessing Cleanliness of Medical Devices

Abstract Recent product recalls relating to device cleanliness have helped to spur activities within the American Standards of Testing and Materials (ASTM). Researchers and engineers from medical device manufacturers, analytical laboratories, NIST, the FDA, and medical device consultants have formed an ASTM task force to address issues of cleanliness in biomedical components, including orthopedics, cardiovascular, dental, and opthamalogical materials. Work is being conducted to develop standards for assessing levels of cleanliness in metallic, ceramic, composite, and plastic components. The task force is also attempting to determine acceptable levels of cleanliness in the various biomedical devices. This paper discusses the current activities within ASTM. Draft testing standards are presented, along with plans for round robin testing.