
Water Testing Resources
for Healthcare and Sterile Processing Professionals
ANSI/AAMI ST108: Standards for Routine Monitoring
of Water Quality in clinical settings
Affirm Documents
Critical Submission Form & IFU
Utility Submission Form & IFU
Affirm Sell Sheet
ST108 Overview
Key Definitions
Critical Water
Critical Water (ST108) is water that meets purity standards for rinsing surgical instruments and medical devices, ensuring patient safety by minimizing organic and inorganic contaminants, microorganisms, and endotoxins.
Utility Water
The initial water coming into a healthcare facility, typically tap water. This water may require additional treatment to meet the quality requirements as outlined in the Standard and can be used for general cleaning tasks such as flushing, washing, and rinsing medical devices.
Endotoxins
A toxin present inside a bacterial cell. When a cell dies and disintegrates, the toxin is released and can be responsible for inflammation or some diseases. After bacteria is killed by a water treatment system (such as with UV) the endotoxins must be filtered out. Measured by Endotoxin Unit (EU).
Water Management Program
A protocol ensuring water quality in medical device processing. An effective program involves a cross-functional team, a risk-based approach, defined roles, verification methods, and documentation standards.
Steam Water
Water that is converted into steam whether from a central steam boiler system or local steam generator for use in medical device sterilization. This water must meet requirements as outlined in the Standard and tested as steam condensate.
Bacteria
A single cell living organism that can cause some diseases. Agenics’ bacteria tests looks specifically for aerobic, heterotrophic bacteria that grows in low nutrient environments, such as water.

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