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The Prion Test is an essential tool to ensure the effectiveness of autoclave sterilization, ensuring that all prions, responsible for Creutzfeldt-Jakob disease, are eliminated. This Class I medical device is designed to monitor "PRION" sterilization cycles using water vapor at 134°C for 18 minutes.
Instructions for Use
- Insertion : Place one Prion test in each pouch to be sterilized before starting the sterilization cycle.
- Visual Indicator : The test exhibits a clear, distinct color change from yellow to black for easy and safe interpretation after sterilization.
- Traceability : Ensures complete traceability of sterilization cycles.
Compliance and Standards
- EN ISO 11140-1 Type 6 Standard : Complies with international standards for chemical indicators, ensuring accuracy in monitoring sterilization conditions (134°C for 18 minutes).
Packaging : Box of 250 pieces.