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 pollution | Researched elements | Acceptance | Analysis method and references |
Total hydrocarbons (THC) | Hydrocarbon | ≤ 0,5 mg/implant | Gas chromatography (NF ISO 9377-2) |
Total Organic Carbon (TOC) | TOC | ≤ 0,5 mg/implant | TOCmeter (NF EN 1484) |
These tests are conducted to determine the absence of manufacturing oil, polishing grease, lubricant, etc. on orthopedic implants.