Analyses based on DIN EN 10993-18

The chemical characterization of materials for medical technology is essential for their use in corresponding areas. In addition to testing services, this also includes knowledge of the materials used, auxiliary and operating materials and changes in the production process.

We offer accredited testing services according to DIN EN ISO/IEC 17025:2018 Certificate Medical Devices (pdf download). One focus is the biological assessment of medical devices based on the standard DIN EN ISO 10993-18, the chemical characterization of the materials used. In addition, we assist you in the assessment of safety data sheets in relation to cmr substances and in the search for possible alternatives.

Our services

Chemical characterization of materials (based on ISO 10993-18)

• Surface composition of plastics, metals and ceramics
• Material composition and microstructure of metals
• Chemical structure and identity of plastics
• Examination for highly volatile and semi-volatile extractable/releasable substances, e.g. CMR substances
• 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
• Investigation of aging effects on metals, plastics and ceramics
• Investigation and evaluation of the passivation quality of stainless steels
• Damage analysis

Methods

• Scanning electron microscopy in combination with energy dispersive X-ray spectroscopy (SEM/EDX)
• Secondary neutral particle mass spectrometry (SNMS)
• Photoelectron spectroscopy (XPS)
• Infrared spectrometry (FTIR)
• Gas chromatography (GC-MS)

Instruments

• FIB/SEM Zeiss Crossbeam 550 with Oxford EDX detector
• FIB/SEM Zeiss Auriga 40
• FIB/SEM Zeiss Crossbeam 350
• SNMS Specs INA-X
• SNMS Specs INA-3
• XPS PHI Quantera SXM
• FTIR Microscope Nicolet iN10
• GC-MS PerkinElmer Clarus SQ8