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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 056 Date of Entry 06/07/2021 
FR Recognition Number 14-562
Standard
ANSI AAMI  ST79:2017 & 2020 Amendments A1, A2, A3, A4
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Scope/Abstract
This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.

The following amendments to ST79:2017 are included in this document: Amendment 1: Environmental services/fans/food and drink; Amendment 2: Inspection of insulated instruments; Amendment 3: Modification of content pertaining to frequency of cleaning for routine care of sterilizers for sterile processing areas in health care facilities; and Amendment 4: Content addressing recording B1 lot numbers in sterilizer records for sterile processing in health care facilities.
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Premarket notification [510(k)] Submissions for Chemical Indicators, Issued December 2003.

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
 Ramesh K. Panguluri
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@fda.hhs.gov
 Grace Levy-Bolton
  CDRH/OPEQ/OHTIV/
  --
  Grace.Levy-Bolton@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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