End-of-life Testing (EOL) An essential part of developing a reusable medical device is determining the maximum use life of the device. Testing for EOL may include a full assessment of biological safety per ISO 10993-1, accumulation of detergents/soils, and device labeling (unique device identification) per MDR. This is done by simulating standard hospital practices for processing devices or following the manufacturer’s instructions for use (IFU). Repeated processing cycles that may include soiling, cleaning, disinfection, and/or sterilization allow manufacturers to assess end-of-life functionality to ensure safe operation during the device’s life cycle. The number of samples recommended for EOL will be determined during the consultation phase of the project.
Applicable Standards
- EU MDR
- ISO 17664
- ISO 10993
- FDA Guidance document on processing/reprocessing 2015
Device Type Expertise*
- Surgical Instruments
- Orthopedics
- ENT
- Dental
- Respiratory
- Flexible/Rigid Endoscopes and accessories
- Robotics
- Dialysis
- Homecare
* Our scope of expertise is continuously expanding. A Nelson Labs expert can help develop methods and test plans for a variety of devices outside of the specifics listed above.
Study Outline
End-of-life studies are custom designed based on standard hospital practices, or on the manufacturer’s cleaning, disinfection, and sterilization procedures for clinical processing. Consult with one of our test experts for specific project details.
