Validation of ultrasonic cleaners
For the validation of ultrasonic cleaners, our validation experts consider the following standards: NEN-EN-ISO 15883-1, NEN-EN-ISO 15883–2, and NPR-CEN-ISO/TS 15883-5.
Validation process
Some materials used during surgeries require additional cleaning due to the presence of hard-to-wash contamination. For this purpose, ultrasonic cleaners are used. Ultrasonic cleaners use sound at very high frequencies to clean medical instruments. To demonstrate that the ultrasonic cleaner is functioning properly, it needs to be periodically validated.
After the identification and technical check of the ultrasonic cleaner, there are two important phases in its validation that must be tested:
Filling the reservoir of the ultrasonic cleaner with water and soap, while the added volume of soap is checked.
The hold time and temperature of the wash phase are monitored with a temperature probe. Additionally, the washing efficiency is checked using wash checks and ultrasonic indicators.
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Agidens has over 25 years of experience in validation & compliance and is a well-known name in the hospital world. Our clients trust us because of our expertise and ‘no nonsense’ approach, and with reliable service, we are a long-term partner.
