Device Functionality Test

An important part of validating the instructions for use (IFU) is determining the life of the device. This requires simulated use testing that mimics clinical conditions and all processing steps. Repeated cycles of dirt, cleaning, disinfection, and / or sterilization exposure allow manufacturers to evaluate end-of-life functionality to ensure safe operation and safety at the beginning, middle, and end of a device's lifespan. The client is based on post exposure functionality testing requirements.

EUROLABhas the equipment and qualified personnel to guide you through the process. Our experts will provide individualized advice and are here to help simplify complex regulatory and standards recommendations.

The standards and details dictating this test:

• MDR (Regulation (EU) 2017/745)
  • Information should be provided that indicates when the device should no longer be reused, eg material deterioration or the maximum number of reuse allowed.
• ISO 17664: 2017
  • MDM should determine if reprocessing has caused degradation to a degree that will limit the useful life.
  • MDM should determine the number of rework cycles or some other indication of end of life
• FDA Guidance Document: 2015, (R) 2017
  • Labeling should report how many times the device can be reused based on the test
  • Provide a mechanism or method to detect whether the device has exceeded its lifespan and whether the device is operating properly

Applicable Standards

• EU MDR
• ISO 17664
• FDA Guidance document on processing / rework of 2015
• AAMI TIR12
• AAMI TIR30 (ST98)
• AAMI ST58
• AAMI ST79
• AAMI ST77
• ISO 11135
• ISO 17665

Sample Features

• RVS110: Minimum 3 devices required
• RVS130: Minimum 1 tray / kit required
• RVS140: Minimum 3 devices required
• RVS180: Minimum 3 devices required

Re-cleaning, disinfection and sterilization studies are specifically designed according to the manufacturer's cleaning, disinfection and sterilization procedures for clinical processing. Consult one of our test experts for specific project details.

EUROLAB, with its highly expert team and internationally accredited laboratories, Device Functionality Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.