ANSI/AAMI ST108- Testing Breakdown

ANSI/AAMI ST108 regulations set quality standards on the water that is used for the sterile processing of medical devices. Many hospitals, clinics, and surgical centers must follow these standards to ensure the safety of their patients.

Get ahead of the curve and start a water testing program for your facility today. By adopting the new ST108 standard, your facility stays up to date and ensures microbiological safety and regulatory compliance. Regular water testing helps detect issues early, helping your team mitigate risk and maintain safe, compliant water systems. This guide will help breakdown the types of testing based on the three water types- critical, utility or steam; and the frequency of testing (routine or annual/validation).

Routine Testing

Routine Testing should be done at regular intervals to comply with ST108 requirements, helping verify that water quality is acceptable day-to-day.

  • Critical Panel: Required monthly- tests include pH, Conductivity, Total Hardness, Alkalinity, HPC, Endotoxin

  • Utility Panel: Required quarterly- tests include pH, Conductivity, Total Hardness, Alkalinity, HPC

  • Steam Panel: Required quarterly- tests include pH, Conductivity, Total Hardness, Alkalinity

Annual (Validation) Testing

Validation testing should be performed with initial system installations, after any repairs or modifications, with the introduction of any new equipment, or annually to ensure ongoing water system performance. Validation testing includes all tests from the routine panels, as well as the tests for the presence of various metals and ions. Annual validation tests include Ionic Panel (Chloride, Nitrate, Phosphate, Sulfate, Iron, Copper, Manganese, Aluminum, Zinc, Silicate), Total Hardness, pH, Conductivity, Appearance, Alkalinity, HPC, Endotoxin, and TOC (Total Organic Carbon).

Individual Testing

We offer tests a-la-carte if you don’t need a full panel. Individual test options include:

  • HPC (Heterotrophic Plate Count)

  • Endotoxin

  • Total Hardness

  • Alkalinity

  • Appearance (Color and Tubidity)

  • Conductivity

  • pH

Our test kits help make water testing simple and easy for your facility. A variety of kits are available depending on your facility’s needs. Kit contents include vials, shipping material, return label, and sampling instructions. Kits are shipped directly to your facility and are ready for use. Reach out to us if you have any questions on what kit your facility needs, or with help finding a custom water testing solution for your facility.

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LAB 797 is introducing Water Testing: USP 1231 & ANSI/AAMI ST108