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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 049 Date of Entry 06/07/2018 
FR Recognition Number 14-511
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
1.1 General
This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling,
cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process
improvement and new product evaluation.
1.2 Inclusions
This recommended practice specifically addresses
a) functional and physical design criteria for sterilization processing areas;
b) staff qualifications, education, and other personnel considerations;
c) processing recommendations;
d) installation, care, and maintenance of steam sterilizers;
e) quality control;
f) product evaluation; and
g) quality process improvement.
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FDA recognition of ANSI/AAMI ST79:2017 [Rec# 14-511] will be superseded by recognition of ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 [Rec# 14-562]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-511] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 14-511] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Premarket notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, Issued December 2003.
FDA Technical Contacts
 Ramesh K. Panguluri
 Clarence Murray
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)
*These are provided as examples and others may be applicable.