Is your water system AAMI ST-108 2023 compliant?

In late 2023, the medical device industry saw a significant shift in direction. The industry saw recommendations and best practices for managing their water system quality become an enforced standard that they must follow. 

This new enforced standard must be followed to ensure compliance, and is guidance on testing, managing, and maintaining your water system and steam quality parameters. Additionally, ST-108 provides guidance on maintaining the highest level of patient safety through having a proper water system design that goes through proper monitoring and maintenance. 

To dive in a bit deeper, ST-108 specifically introduces and details 3 water quality categories that directly impact the reprocessing workflow of your medical devices that includes testing quality parameters for:

• Utility Water – Includes the most basic form of water used.
• Critical Water – Includes water used in the final rinsing of sterilized medical devices.
• Steam – Includes steam produced by a boiler system or a steam generator. Steam quality parameters are tested as condensate water.

This is where Alcami can come in to help you. We can collect and test your water and steam condensate samples to ensure your water system parameters meet the needs of water and steam safety for the processing of your medical device.

Want to know more about how to meet ST-108 requirements? Contact us