AAMI ST108 Compliance Services

Protect Patients, Instruments, and Your Facility

Water is one of the most important, and often overlooked, components of sterile processing. ANSI/AAMI ST108 establishes the industry standard for water quality used in the cleaning, rinsing, disinfection, and sterilization of reusable medical devices.

At IWC Innovations, we help hospitals, ambulatory surgery centers, and sterile processing departments develop, implement, and maintain comprehensive ST108 water management programs designed for long-term compliance.

What Is AAMI ST108?

ANSI/AAMI ST108:2023 is the national consensus standard for water used in medical device processing. It replaced AAMI TIR34 and establishes requirements for:

  • Water quality selection
  • Water treatment system design
  • Routine testing and monitoring
  • Steam quality
  • Documentation and quality improvement
  • Water management responsibilities across multiple departments

The standard defines three categories of water used throughout sterile processing:

  • Utility Water – Used for washing, flushing, and intermediate rinsing.
  • Critical Water – Highly treated water used for final rinses and steam generation.
  • Steam – Steam used during sterilization that must meet specific purity requirements.

Evaluate Your ST108 Readiness

Our ST108 Assessment evaluates your water systems, treatment equipment, and processes to identify compliance gaps and opportunities for improvement. You’ll receive clear, actionable recommendations to help protect medical devices, improve water quality, and confidently prepare for ST108 compliance.

Our ST108 Compliance Services

Compliance Assessment

  • Review current water system, monitoring practices, documentation, and testing records.
  • We provide a gap analysis, risk score, and a compliance roadmap to ensure full compliance with ST108.

Water Quality Testing Program

  • Testing support for utility water, critical water, and steam condensate.
  • We provide sampling, ST108 Water Management Plan, trending reports, corrective action support, survey readiness documentation, and annual account review.

Who We Serve

Our ST108 services are designed for:

  • Hospitals
  • Ambulatory Surgery Centers (ASCs)
  • Outpatient Surgery Centers
  • Sterile Processing Departments (SPD)
  • Healthcare Systems
  • Specialty Surgical Facilities

Why Choose IWC Innovations?

Healthcare organizations across the country trust IWC Innovations because we build sustainable compliance programs.

Our team combines expertise in:

  • Water treatment engineering
  • Healthcare water management
  • Sterile processing
  • Regulatory compliance
  • Legionella risk management
  • Ongoing service and support

Our goal is to help facilities move beyond simply passing inspections and build water management programs that improve safety and operational performance.

FAQ's About ST108

Is ST108 Required?

While ST108 itself is an industry consensus standard rather than a federal law, accrediting organizations and healthcare surveyors increasingly reference AAMI standards as recognized best practices during inspections and accreditation activities

How often should water be tested?

Testing frequency depends on the type of water and system being monitored. ST108 establishes routine monitoring requirements for both water generation systems and points of use.

Does my facility need a reverse osmosis system?

Not every facility requires the same treatment technology. The appropriate solution depends on your incoming water quality, equipment, and processing needs. A comprehensive assessment determines the most effective treatment approach.

Can you help us prepare for surveys?

Yes. We help facilities establish documentation, monitoring programs, testing schedules, and reporting practices that support accreditation readiness.

ABOUT IWC INNOVATIONS

Based in Indianapolis and founded in 2016, IWC Innovations delivers value-driven water treatment solutions focused on safety, compliance, and performance. We offer Legionella testing, remediation, and pathogen monitoring, plus ASHRAE 188 and CMS-compliant water management plans. Our services cover filtration, secondary disinfection, and tailored treatment for cooling towers, closed loops, and boilers. We also provide high-purity water services—including pretreatment, diagnostics, repairs, and ST108 support—for healthcare, industrial, and commercial clients. IWC is dedicated to keeping water systems safe, efficient, and compliant.