The importance of ensuring your products and instruments are clean and sterile every time they come into contact with a patient or end user cannot be overstated. The burden of responsibility falls on the manufacturers of finished medical devices to provide clear, understandable and reproducible cleaning and sterilization protocols that have been validated to be effective.
With more than 30 years of experience in this field, Eurofins Medical Device Testing network of laboratories offers a broad range of microbiological, bio-/chemical and toxicological testing to examine products for the intended reprocessing procedures according to AAMI ST 12, ISO 17664-1 and ISO 17664-2 to validate procedures for manual and automatic cleaning, disinfection and sterilization.
What do we offer?
- Evaluate the effectiveness of your cleaning, disinfecting and sterilization protocols
- Select the most appropriate test soil or organism to simulate practical use
- Identify inoculation sites on your instruments which represent worst case challenges (Consultancy)
- Optimize your Instructions for Use (Consultancy)
- Complete your regulatory dossiers with proven validation reports (Consultancy)
Available testing
- Simulated Use Cycles
- Manual Cleaning
- Automated Cleaning
- Chemical Disinfection (Low Level Disinfection, Intermediate Level Disinfection, High Level Disinfection)
- Thermal Disinfection (Manual and Automatic)
- Sterilization (Dynamic Air Removal, Gravity Displacement)
- Analysis of Chemical Residual
- Analytes (Visual Evaluation, Protein, Hemoglobin, Total Organic Carbon (TOC), Cytotoxicity)
Instrumentation
- Shakers
- Ultrasound Baths
- Washer Disinfectors
- Moist Heat Sterilizers
- TOC Analyzers
- Microplate Readers
Why choose Eurofins Medical Device Services?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of regulatory experts, laboratories, and sterile packaging sites in Europe, North America, & Asia Pacific, we can offer a comprehensive service portfolio to our customers.
- Extensive expertise. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.
If you want to discuss your project with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.
If you would like more information about our Medical Device testing capabilities, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
