Chemical Characterization

When proving the biological safety requirements of the medical device, if you do not have enough data, you should carry out chemical characterization studies taking into account EN ISO 10993-18. These studies are carried out to reveal the potential of your product to physically harm the biological functioning of the body, by leaving your product or with chemicals that interact biologically with the body by surface contact. For this reason, all kinds of materials/chemicals that may contaminate the product are within the scope of this assessment, as well as the chemical and physical structure of the medical device. What needs to be considered is the total exposure carried by the finished product and from the entire life cycle.

It is not any test of presence or absence explained by standards. A material that only has a toxic effect will not be harmful on its own, and if such a material is present in the product, the risk level should be measured by making a quantitative assessment at the same time.

We provide you with a Chemical Evaluation and Biological Evaluation Plan by examining all life cycles of your medical device. After this plan, we prepare the Biological Evaluation Report by conducting the targeted tests and evaluating the results. If there is a residue/contaminant that cannot be tolerated in the processes, we support the improvement and validation of the production process.

Evaluation processes cannot be conducted separately from design review and validation. In terms of product safety and performance, the doors of continuous improvement should always be open.