Chemical characterization is the design process in terms of risk analysis, material selection, and medical devices before the production of medical devices. In chemical characterization, with the revision to the ISO 10993-1 standard, it is included in the definition of the chemical components of indirect and direct contact medical devices in the risk assessment process. It was also stated that material characterization should be done.
The biological evaluation of ISO 10993-18 medical devices and the determination of the chemical properties of the material are also related to chemical characterization. Consideration is given to an appropriate toxicological assessment and chemical characterization to determine if further testing is required.  Historically, the evaluation of the safety of new medical devices has been done by different methods. However, characterization studies are carried out in order to fully understand the risk factors associated with the use of devices.

Chemical Characterization Test

The chemical characterization test includes various analytical techniques to detect and measure the materials that pass into the solution from the material in contact with the products. This determined test is generally used to identify product materials, detect the presence of impurities or create a chemical profile in an unknown formulation. Many different chemical characterization techniques are used in the laboratory developed for this purpose. ÖFor example:
The inductively coupled plasma technique is used in the analysis of extract samples for metals.
The liquid chromatography technique determines the presence of peaks corresponding to non-target, non-volatile organic compounds.
The liquid chromatography technique is used in the analysis of extract samples for target non-volatile organic compounds.
Gas chromatography technique is used in the analysis of extract samples in terms of volatile organic compounds and semi-volatile organic compounds.

Medical Device Chemical Characterization Services

Teams of analytical chemists can work with customers to determine the most suitable extraction conditions and extraction protocols for device characterization. Extractions can be extensive, simulated use, and exaggerated. It also provides toxicological risk assessment reports with chemical characterization studies. It has been operating for many years, and medical device and medicine; Provides toxicology consulting services.
In general, physical and chemical characterization of materials was the first stage of biocompatibility testing in accordance with ISO 10993-1 2018. Chemical and material characterization tests are aimed to evaluate the risk of chemicals leaking in the product and product package during the contact process with the body, and to analyze the effect of this on biocompatibility performance.