Leading to competitiveness through innovation in medical devices, biomaterials, and processes.

Testing

Biomaterials & medical devices analysis
and mechanical testing

Products and Packaging Validation

Cleaning Validation

Testing method to validate the cleaning process in terms of organic content on medical devices has been established following the proposed standard XP S 94-091.

Type of pollutionResearched elementsAcceptanceAnalysis method and references
Total hydrocarbons (THC)Hydrocarbon≤ 0,5 mg/implantGas chromatography (NF ISO 9377-2)
Total Organic Carbon (TOC)TOC≤ 0,5 mg/implantTOCmeter (NF EN 1484)

These tests are conducted to determine the absence of manufacturing oil, polishing grease, lubricant, etc. on orthopedic implants.