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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 14-478
Standard
ANSI AAMI ST91:2015
Flexible and semi-rigid endoscope processing in health care facilities
Scope/Abstract
Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.
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.
Transition Period
FDA recognition of ANSI/AAMI ST91:2015 [Rec# 14-478] will be superseded by recognition of ANSI/AAMI ST91:2021 [Rec# 14-572]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-478] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 14-478] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued June 2017.



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
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
 Stephanie Cole
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA
  301-796-8587
  stephanie.cole@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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