AAMI ST-108 Testing Lab
ANSI/AAMI ST108:2023 sets specific requirements for both routine monitoring and performance qualification (PQ) sampling for water systems used in processing medical devices. The frequency and parameters tested depend on the type of water system and water quality category.
The standard defines three water categories based on their quality and use:
- Utility Water: Tap water that may require further treatment for cleaning and rinsing.
- Critical Water: Extensively treated water used for final rinses and steam generation.
- Steam: Water heated to a vapor phase for sterilization.
