The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.
Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.
Biological evaluations address a device’s biocompatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.