“Currently, there are no consensus methods for characterizing the detergents intended to clean medical devices,” said Ralph Basile, vice president of marketing and regulatory affairs at Healthmark Industries. “The result is that very little detail about detergents intended to clean medical devices is available.”
Basile said that the committee will work to identify existing test methods that could help detergent manufacturers describe the physical and performance characteristics of their products. In turn, the committee will work to identify and fill any gaps for new test methods that need to be created.
Ultimately, manufacturers could reference that they conducted tests according to the standard when taking their products to market.
Manufacturers of cleaning agents intended for medical devices, and other interested parties, are invited to join in creating and revising the standard, said ASTM.