Hohenstein Laboratories GmbH & Co. KG

As an ISO 17025 accredited and GLP-certified testing laboratory, we offer various chemical, physical and biological safety and efficacy tests for medical devices.

Our focus is on the area of basic safety and performance requirements (GSPR) according to MDR with a focus on biocompatibility testing according to ISO 10993 and ISO 18562.

At our main site in Baden-Württemberg, we have various sample preparation and analysis techniques that are necessary for testing and assessing biocompatibility.

In addition, we have a broad portfolio of other methods and test procedures to provide individual solutions for our customers. We look forward to your inquiry!

Biocompatibility testing (ISO 17025/ GLP):

• ISO 18562-2
• ISO 18562-3
• ISO 18562-4
• ISO 10993-18
• ISO 10993-12
• ISO 10993-5
• ISO 10993-23
• ISO 10993-10

Further tests:

• ISO 11737 (Bioburden)
• TOC tests (GC-FID)
• Endotoxin test (LAL test)
• Antimicrobial efficacy
• Reprocessing and cleaning validation (ISO 17664)
• Ageing tests and degradation products
• Effectiveness of disinfectants (VAH methods)

17025 accredited and GLP-certified testing laboratory with various chemical, biological and physical analysis techniques, including:

• Gas chromatography: thermodesorption, GC-MS, GC-MS/MS, GC-FID, headspace-GC-MS
• Liquid chromatography: LC-qTOF, LC-MS, LC-MS/MS, LC-DAD, LC-FLD
• Inductively coupled plasma (ICP-MS)
• Surface analysis (REM/XRD)
• Microbiological purity and efficacy
• Cleaning validation (ISO 17664)