A medical device, or a material used in a medical device, that comes into direct contact with patients must be able to perform its intended function without inducing significant rejection.

The chemical analysis of a medical device generally includes a wide range of tests and product evaluations, such as:

•    Physicochemical characterization of materials 
•    Morphological characterization of materials 
•    Assays and residual tests 
•    Degradation products 
•    Leachables and extractables 
•    Ethylene oxide and related degradation products 
•    Storage and stability studies

Mar, 21st Mar, 22nd
2019