Taking fingerprints of medical devices – Chemical characterisation according to ISO 10993-18

By Dr. Enrico Franzoni, Eurofins BioPharma Product Testing, Italy, and Dr. Christoph Höppner, BSL Bioservice GmbH, Germany

As part of the biological evaluation of medical devices as described in the ISO 10993 series, Eurofins BioPharma Product Testing and BSL BIOSERVICE (a Eurofins partner laboratory) joined forces to offer testing services for medical devices as outlined in ISO 10993-18. To compare medical device products after design and material change, we have created the "GC/HPLC/ICP fingerprint," a standardised service for chemical characterisation of MDs.

Even for complex geometry, materials and consistency, we offer solutions to prepare, extract and analyse in full compliance with ISO 10993-18. High accuracy and sensitivity are guaranteed by fully validated analytical methods.

BSL BIOSERVICE is specialised in performing GC-fingerprint using a GC-FID/ MS setup, which provides both high identification rates within NIST mass spectral library and excellent linear range of the FID-based quantification method.

Eurofins BioPharma Product Testing is able to perform screening of more than 35 inorganic elements by ICP technique and is equipped with two kinds of LC-MS for organic non-volatile compounds: Ionic Trap and Q-TOF with an internal database of more than 100 known compounds that is constantly updated.

Our multi-disciplinary team of analysts and toxicologist is proficient in researching and concluding expert statements about the detected chemical substances and will leave no question unanswered.

Contact: EnricoFranzoni@eurofins.com; choeppner@bioservice.com