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Chemical Characterization of Materials

Standard ISO 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 . During the 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 introduced during manufacturing 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 clinical condition of use
  • Determination of chemical substances released by medical devices under clinical condition of use

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+86 571 8720 6559 (EN)
Contact Us
+86 571 8720 6559 (EN)