1. Overview
Our center conducts cleaning performance evaluation tests for reusable medical devices in accordance with various international standards, including AAMI ST98. Cleaning performance is evaluated by measuring residual proteins and other organic contaminants remaining after cleaning performed in accordance with the device’s Instructions for Use (IFU) or a cleaning 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 ST98 – Cleaning validation of reusable medical devices
・ASTM F3208 – Standard guide for evaluating cleaning validation
・ISO 15883 series – Washer-disinfectors and cleaning validation
・ISO 17664 / JIS T 17664 series – Processing information to be provided by the medical device manufacturer
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.
Example test procedure:
1) Contamination of medical devices using artificial soil (mixture of blood and protein)
2) Implementation of the cleaning process based on the IFU
3) Visual inspection (photographic documentation), measurement of residual protein amount, carbohydrate amount, and TOC amount
