1. Overview
Our center conducts disinfection performance evaluation tests for reusable medical devices in accordance with various international standards, including AAMI TIR12, ISO 15883 series, EN standards, and ASTM standards. Disinfection performance is evaluated by quantitatively measuring the number of residual microorganisms after disinfection performed in accordance with the device’s Instructions for Use (IFU) or a disinfection procedure specified by the client.
These evaluations support compliance with FDA and European regulatory requirements, reduce risks associated with market introduction, and enhance confidence in device reprocessing in clinical settings.
2. Applicable Products
・Medical devices and equipment
・Washer-disinfectors
3. Standards and Regulations
・AAMI TIR12 – Technical Information Report for the reprocessing of reusable medical devices
・ISO 15883 series – Performance requirements for washer-disinfectors
・EN and ASTM standards for disinfectants – Evaluation of the antimicrobial efficacy of disinfectants
4. Test Method
Our center has extensive experience in evaluating endoscopes, endoscope washer-disinfectors, ultrasound probes, dental equipment, and other reusable medical devices.
Testing is performed by personnel certified as Second-Class Sterilization Technicians by the Japanese Society of Medical Instrumentation, and we can also provide recommendations regarding appropriate test conditions and study design.
Examples test procedure:
1) Contaminate the medical device with the test microorganism.
2) Perform the disinfection procedure in accordance with the device’s IFU or a specified protocol.
3) Determine the number of surviving microorganisms.
4) Calculate the log reduction value (LRV) to evaluate disinfection performance.
