What Is AAMI ST108?
by Ben Frieders
AAMI ST108 is an American National Standard that provides guidance on the quality of water used in the processing of reusable medical devices. It was published in 2023 and supersedes the previous standard, AAMI TIR34.
The standard covers the following topics:
- Water quality requirements for cleaning, rinsing, and sterilizing medical devices
- Methods for monitoring and testing water quality
- Maintenance and troubleshooting of water systems
- Risk management for water quality
AAMI ST108 is intended to help healthcare facilities ensure that the water used to process medical devices is of sufficient quality to prevent the spread of infection. The standard is based on the principles of risk management and takes into account the latest scientific evidence on the relationship between water quality and patient safety.
Some of the key requirements of AAMI ST108 include:
- Water used for cleaning and rinsing medical devices must be free of bacteria, endotoxins, and other contaminants.
- Water used for sterilizing medical devices must meet the requirements of the specific sterilization process being used.
- Water systems must be monitored and tested on a regular basis to ensure that they are meeting the required water quality standards.
- Any problems with the water system must be identified and corrected promptly.
AAMI ST108 is an important resource for healthcare facilities that need to ensure the quality of water used in the processing of medical devices. By following the requirements of this standard, healthcare facilities can help to protect patients from the risk of infection.
In addition to the requirements listed above, AAMI ST108 also provides guidance on the following topics:
- The design and installation of water systems
- The selection of water treatment equipment
- The training of personnel responsible for water quality
The standard is intended to be used by a variety of stakeholders, including healthcare facilities, water treatment companies, and equipment manufacturers. It is a valuable resource for anyone who needs to ensure the quality of water used in the processing of medical devices.
You can read more about the Standard on the AMMI’s website.
ChemREADY is an experienced provider of sterile water treatment solutions for medical facilities of all types, and able to provide a complete system evaluation, recommendations and the equipment and treatment necessary to help prepare for the upcoming AAMI ST108 Standard. For more information and assistance with your ST108 compliance, visit our page on ST108 Testing.
About The Author
Ben Frieders is the Business Development and Marketing Manager at ChemREADY, an industrial water treatment company, where he focuses on driving growth through strategic marketing, business development, and acquisitions. A former U.S. Navy Chief Petty Officer with a background in nuclear operations, Ben brings a unique blend of technical expertise and leadership to the water treatment industry. Certified in ASSE 12080 Legionella Water Safety and Management, he is a recognized expert in water quality standards, regulatory compliance, and Legionella risk management. Passionate about scaling businesses and optimizing systems, Ben combines data-driven strategies with a hands-on approach to help organizations achieve sustainable growth.
