Accredited Testing Services

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

+49 7121 51530-863

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Accredited testing services according to DIN EN ISO/IEC 17025:2018 for chemical characterization of materials for medical devices

Numerous tests must be carried out before a medical device can be placed on the market. The NMI provides support on the question of which tests are necessary within the framework of the Medical Device Regulation (MDR).

We offer accredited testing services according to DIN EN ISO/IEC 17025:2018, certificate Medical Devices (pdf download). One focus is on the biological assessment of medical devices, based on the DIN EN ISO 10993 series of standards, and in particular the chemical characterization of the materials used. We also assess surfaces for cleanliness and materials for material compliance, aging effects and CMR substances.

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.

• Assessment of surfaces for cleanliness
• 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)

Devices

• 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 Mikroscope Nicolet iN10
• GC-MS PerkinElmer Clarus SQ8