Scientists from the FDA, American Dental Association, medical device companies, and contract research laboratories were asked to present to Peruvian medical device regulators and manufacturers on how ASTM standards benefit their organizations in helping to get safe and effective medical devices into the patients who need them. Peru has a keen interest in improving their adoption of standards for material and product testing in order to market safe products both in Peru and outside of Peru.
Dr. Stephen Spiegelberg from Cambridge Polymer Group spoke about his ASTM task group on Medical Device Cleanliness, and provided examples of what can go right and what can go wrong when ASTM standards are not properly used, particularly with respect to validation of medical device cleaning lines.
Read more in this ANSI article and this ADA article.