Products and Packaging 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.