RMS Foundation
Bischmattstrasse 12
2544 Bettlach
Switzerland
Phone +41 32 644 2000
METHODS
Chemical characterization of medical devices
As a first step in assessing the biocompatibility of a medical device, a thorough investigation of its chemical or material composition is essential. ISO 10993‑18 provides a framework for identifying and quantifying both the components of a medical device and substances that may be introduced during manufacture. To this end, the standard specifies a multitude of analytical techniques available at the RMS Foundation.
In addition, the standard provides for the estimation of substances released from a medical device into the human body (more information can be found here).
According to which standards do we test?
The service offered is provided in accordance with the following standards:
- ISO 10993-18
- Method-specific standards, depending on material and question
Which devices do we use?
The service offered is carried out with the following analysis systems:
- GC-MS (gas chromatography with mass spectrometry): Thermo TRACE 1310 GC + TSQ 9000 mass spectrometer
- FTIR (Fourier transform infrared spectrometry): FT-IR microscope Bruker Lumos
- XPS (X-ray photoelectron spectroscopy): Kratos axis Nova
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry): Agilent 7700x ICP-MS
- TOC (total organic carbon), TIC (total inorganic carbon), TN (total nitrogen): Shimadzu TOC-L Analyzer
- XRD (X-ray diffraction): Bruker D8 Advance
- XRF (X-ray fluorescence analysis): Bruker S8 Tiger
- SEM/EDX (scanning electron microscopy with energy dispersive X-ray spectroscopy): Zeiss Sigma 300 VP + UltimMax 40 EDX detector
- TGHE (carrier gas hot extraction): LECO CS 230 / Bruker G8 Galileo & mass spectrometer ESD 100
- DSC (Differential Scanning Calorimetry): Mettler STAR System DSC1
What you should know about this method?
Below are some questions you may have and which we will be happy to answer. If your question is not listed, please contact us and we will discuss your problem in a personal meeting.
Which products can be tested at the RMS?
We test all products. Contact us and we will discuss your individual problem.
Are the RMS analyses accredited?
RMS is an ISO 17025 accredited analytical laboratory (accreditation type C). Many of the analyses are already validated. New or customer-specific analysis methods can be validated and accredited by us.
Who is your contact person?
Christoph Stähli
Dr., MSc EPFL Mat. Sc.
Senior Scientist Bioceramics
+41 32 644 2044