1. Overview
Our center conducts sterilization performance evaluation tests for reusable medical devices in accordance with various international standards. Sterilization performance is evaluated by qualitatively or quantitatively assessing residual microorganisms following sterilization performed in accordance with the device’s Instructions for Use (IFU) or a sterilization 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
・Reusable medical devices
・Medical instruments
・Dental equipment
・Sterilizers
Testing using sterilizers provided by the client can also be accommodated.
When installing heavy equipment, please ensure that load-distributing boards or equivalent measures are used so that the floor loading does not exceed 500 kgf/m². In addition, please confirm the transportation route in advance before delivery and installation of the equipment.
3. Standards and Regulations
・Relevant ISO, AAMI, and JIS standards applicable to each sterilization method
4. Test Method
Our center has extensive experience in evaluating hydrogen peroxide gas plasma sterilizers, vaporized hydrogen peroxide sterilizers, tabletop steam sterilizers for medical use, medical waste sterilizers, 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.
Example test procedure:
1) Inoculate the medical device with a biological indicator (BI).
2) Perform the sterilization procedure in accordance with the device’s IFU or a specified protocol.
3) Incubate the biological indicator and evaluate sterilization performance qualitatively or quantitatively.
