An essential part of validating the instructions for use (IFU) is to determine the use life of the device. This requires simulated-use testing that mimic clinical conditions and the full processing steps. Repeated soiling, cleaning, disinfection, and/or sterilization exposure cycles allow manufacturers to assess end-of-life functionality to ensure safe operation and safety at the beginning, middle, and end of a device’s life cycle.The number of samples is determined by the customer based on their post-exposure functionality test requirements.
Nelson Labs has the equipment and qualified personnel to help guide you through the process. Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations.
Standards and verbiage that dictate this testing:
- MDR (Regulation (EU) 2017/745)
- Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.
- ISO 17664:2017
- MDM must determine if reprocessing leads to a degree of degradation that will limit the useful life
- MDM must determine the number of reprocessing cycles or other indication of the end of its life
- FDA Guidance Document: 2015, (R) 2017
- Labeling should inform how many times the device can be reused based on testing
- Provide a mechanism or method to ascertain whether the device has exceeded its use life and if the device is functioning properly
Applicable Standards
- EU MDR
- ISO 17664
- FDA Guidance document on processing/reprocessing 2015
- AAMI TIR12
- AAMI TIR30 (ST98)
- AAMI ST58
- AAMI ST79
- AAMI ST77
- ISO 11135
- ISO 17665
