Material Characterization

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

+49 7121 51530-863

E-Mail

anzeigen

Dr. Xin Xiong
Group Leader Biofunctionalized Surfaces

+49 7121 51530-413

E-Mail

anzeigen

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
• Carrying out degradation tests (metal, alloy, polymer, biopolymer)
  • Detection of degradation products (based on DIN EN ISO 10993-13 and -15)
  • Simulated applications and stability testing of medical devices
  • Release kinetics of active ingredients and degradation products from medical devices/pharmaceutical formulations
  • Identification and quantification of active ingredients according to USP
  • Mechanical properties by means of rheology
  • Analysis of layer structure and thickness (QCM, ellipsometry, zeta potential)
  • Polymer analysis (MALDI-TOF, HPLC/SEC)

Methods

• Secondary neutral particle mass spectrometry (SNMS)
• Photoelectron spectroscopy (XPS)
• Angle-resolved photoelectron spectroscopy (ARXPS)
• Infrared spectrometry (FTIR)
• Raman spectrometry
• Gas chromatography (GC-MS)
• Spectroscopic methods: UV/VIS spectroscopy (ISO 17025 accredited), fluorescence spectroscopy, FTIR
• Optical methods: light microscopy, fluorescence microscopy
• Mass spectrometric methods: MALDI-TOF, ICP-MS
• Layer characterization: ellipsometry, QCM, zeta potential (2D)
• Chromatographic methods: HPLC (ISO 17025 accredited), SEC
• Thermal analyses: DSC (differential scanning calorimetry), melting point determination
• Rheological tests

Devices

• SNMS Specs INA-X
• SNMS Specs INA-3
• XPS PHI Quantera SXM
• FTIR Microscope Nicolet iN10
• GC-MS PerkinElmer Clarus SQ8
• UV/Vis Spectroscopy
• JASCO V630, FTIR Thermo fisher
• MALDI-TOF Ultraflextreme Brucker
• ICP-MS Analytik Jena
• HPLC Agilent Infinity 1260
• DSC Netzsch
• Anton Paar Rheometer
• Anton Paar Digestion microwave

• Anton paar Surpass 3