Chemical Characterization

As an ISO 17025 accredited laboratory, we 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 network of laboratories offers comprehensive chemical characterization services according to ISO standards, including:

Chemical Characterization of Materials (ISO 10993-12, 18, 19)
Identification and Quantification of Degradation Products (ISO 10993-13, 14, 15)
Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
Ethylene Oxide Sterilization Residuals (ISO 10993-7)

Choose Eurofins Medical Device Testing to help you:

Confirm the purity of raw materials
Characterize the degradation and dissolution of resorbable polymer devices or bone ingrowth coatings
Ensure the safety profiles of processing aids or additives used in plastic devices
Assess the impacts of changes to raw material suppliers, processing techniques or sterilization methods
Ensure products are free of processing contaminants and residuals, such as machining oils and cutting fluids

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