Chemical Characterisation

As an ISO 17025 accredited laboratory, we recognise that 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 customised testing programmes, within a risk-based approach, for chemical characterisation of their products and materials.

Eurofins Medical Device Testing network of laboratories offers comprehensive chemical characterisation services according to ISO standards, including:

• Chemical Characterisation 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 Sterilisation Residuals (ISO 10993-7)

Choose Eurofins Medical Device Testing to help you:

• Confirm the purity of raw materials
• Characterise 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 sterilisation methods
• Ensure products are free of processing contaminants and residuals, such as machining oils and cutting fluids