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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 14-597
Standard
AAMI ANSI  ST108:2023
Water Quality for Processing Medical Devices
Scope/Abstract
This standard covers the selection and maintenance of effective water quality suitable for processing medical devices. It provides guidelines for selecting the water quality necessary for the processing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.1500 Endoscopic Access Overtube, Gastroenterology-Urology Class 2 FED
§880.6880 Sterilizer, Steam Class 2 FLE
§880.6885 Sterilant, Medical Devices Class 2 MED
§880.6991 Device, Pasteurization, Hot Water Class 2 LDS
§880.6992 Cleaners, Medical Devices Class 2 MDZ
§880.6992 Disinfector, Medical Devices Class 2 MEC
21 CFR 801 Labeling
21 CFR 820.3 Definitions
Relevant FDA Guidance and/or Supportive Publications*
1. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.

2. Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers, issued January 2000.

3. Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices, issued June 1998.

4. Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities, issued August 1993.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Christopher Dugard
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-6031
  christopher.dugard@fda.hhs.gov
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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