Recognized Consensus Standards: Medical Devices

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 for the processing of 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