Material Characterization

Dr. Dagmar Martin
Group Leader Interface Analysis in the Production Process

+49 7121 51530-863

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Materials used for medical devices must be comprehensively characterized. Characterization includes knowledge of materials used, auxiliary and operating materials, and changes in the production process.

High requirements are placed on materials used in medical devices. For example, according to the MDR, they may only contain cmr substances in a concentration above 0.1 percent by mass if there is a special justification for the presence of these substances. One such substance is cobalt, which occurs both in CoCr alloys and as an impurity in stainless steels or other metals. In addition, we offer analytical testing services to characterize your materials.

Our services

• Detection of cmr substances from plastics following 10993-13
• Detection of cmr substances in metals, e.g. Co in stainless steels, titanium Nitinol
• cmr evaluation of the materials used on the basis of safety data sheets
• Search for substitutes

Methods

• Secondary neutral particle mass spectrometry (SNMS)
• Photoelectron spectroscopy (XPS)
• Angle-resolved photoelectron spectroscopy (ARXPS)
• Infrared spectrometry (FTIR)
• Raman spectrometry
• Gas chromatography (GC-MS)

Devices

• SNMS Specs INA-X
• SNMS Specs INA-3
• XPS PHI Quantera SXM
• FTIR Microscope Nicolet iN10
• GC-MS PerkinElmer Clarus SQ8