Chemical and Physical Analysis

From a diabetic infusion set to devices for in-vitro fertilization, medical devices encompass a very broad and complex variety of technologies. Since devices have a very broad range, so are tests and testing requirements for safety. We as Eurofins recognize the needs of our customers are as unique as the medical devices they produce. With a broad range of equipment, including over 500 chromatography systems, our highly trained chemists provide customers the opportunity to leverage our extensive analytical resources and expertise to develop customized testing programs, within a risk-based approach, for chemical characterization of their products and materials.

Eurofins Medical Device Testing offers comprehensive chemical characterization services according to ISO standards, including:

  • Chemical Characterization of Materials (ISO 10993-12, 18, and 19)
  • Identification and Quantification of Degradation Products (ISO 10993-13, 14, and 15)
  • Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
  • Residual Ethylene Oxide (ISO 10993-7)
  • Material & Product stability
  • Dissolution
  • Raw material purity
  • Particle Size
  • Unaxial mechanical Testing 

 


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