In 2023, the Association for the Advancement of Medical Instrumentation (AAMI) published, ANSI/AAMI ST108:2023 (ST108) – Water for the Processing of Medical Devices. This new water quality standard replaces AAMI TIR34:2014, the standard that previously set requirements for processing and cleaning of medical devices. This new standard is directed at providing medical professionals with information and testing requirements specifically for the water used in these processes. The unique usage of this water requires that they meet strict performance standards not only for the chemical makeup of the processing water, but also for microbiological contamination.
From the AAMI website:
Water impurities can have adverse effects to medical device processing…Water of the appropriate quality for the processing of medical devices prior to clinical use is an important part of the solution to these problems.
EST is excited to announce that we are now offering all analytical services necessary to be in compliance with ANSI/AAMI ST108:2023. These include the general requirements that are to be tested for monthly or quarterly, depending on the system (Critical, Utility or Steam) to be evaluated.
In addition to the general requirements that are monitored monthly or quarterly the following ionic contaminates need to be evaluated annually:
Based on their need for water to be used in the processing of medical devices, healthcare providers and watercare professionals may need to begin a testing program for ST108. For more information or to begin sampling, check out our website at the link below.
Learn More About ST108 Here.
