Definition of Extractables and Leachables
Extractables are substances which could be potentially released from polymeric, metallic or glass material of medical device using extraction solvents and/or extraction conditions into the patient or consumer; such as dyes, catalysts and plasticizers.
Leachables are substances which do migrate from a medical device into the patient under intended use conditions, typically a subset of those identified in the extractables analysis. https://www.ste-mart.com/extra....ctables-leachables.h
