Chemical Characterization of Medical Device Materials: A Stepwise Approach for Biosafety Evaluation
Chemical characterization of medical device materials involves identifying materials and determining chemical substances in them or finished devices, and it's part of medical device biosafety evaluation. The generation of chemical characterization data is a step - by - step process linked with risk assessment, including qualitative material analysis, isotropic analysis of materials, obtaining quantitative information, quantitative risk assessment, and evaluating chemical clinical exposure. Qualitative and quantitative material information should be combined with supplier information and extraction experiments. A complete study combines qualitative information for material isotropy research, quantitative information for risk assessment, and evaluation of clinical contact compounds. Chemical characterization can exempt some long - term biocompatibility tests to shorten the test cycle.
Chemical characterization of medical device materials refers to the identification of materials and the qualitative and quantitative determination of chemical substances present in materials or finished medical devices.
It is a part of the overall biosafety evaluation of medical devices.
The generation of chemical characterization data is a step-by-step process linked with risk assessment, which is carried out in five steps:
Step 1: Qualitative material
Step 2: Isotropic analysis of materials
Step 3: Quantitative information
Step 4: Quantitative risk assessment
Step 5: Evaluate the presence of chemical clinical exposure
In general, the qualitative and quantitative information of materials should be combined with the information provided by the material supplier and the extraction experiment.
A complete study of the chemical characterization of materials needs to combine the above qualitative information to conduct material isotropy research, quantitative information to conduct quantitative risk assessment and the final evaluation of clinical contact compounds.
By means of chemical characterization, some long-term tests in biocompatibility tests can be exempted, such as subchronic toxicity, chronic toxicity and long-term implantation, so as to shorten the test cycle.
