Chemical Characterization of Materials

StandardISO 10993-1 and GB/T16886.1 provide a framework for biological evaluation. With the development of scientific knowledge, biological evaluation system also needs to gradually transform from traditional biocompatibility tests to modern concepts based on risk assessment .Duringthe risk assessment process, priority is given to the evaluation of chemical/physical properties and in vitro model tests.

Chemical characterization services of medical device materials:

• Identification of the materials of construction of the medical device
• Characterization of manufacturing materials through qualitative and quantitative chemical composition of materials
• Medical device characterization for chemical substances introducedduringmanufacturing process (e.g.processing aids, process contaminants, sterilization residues)
• Estimation of the possibility of releasing chemical substances from medical devices or their manufacturing materials under clinicalcondition ofuse
• Determination of chemical substances released by medical devices underclinicalcondition ofuse

Service Process: