There is no published standard for encrustation testing on urinary medical devices.
Not one.
The closest, ASTM E3321-21, covers E. coli biofilm on catheters. It doesn’t touch encrustation, doesn’t address the broader microbial picture, and doesn’t capture the interaction between biofilm and mineral buildup.
For manufacturers developing anti-encrustation coatings, that gap makes it hard to compare performance, meet regulatory expectations, or move confidently to clinical trials.
Our new white paper covers the current testing landscape and what validated, high-throughput methods look like in practice.
#MedicalDevices #RegulatoryAffairs #DeviceTesting #UrologicalDevices #Innovotech
