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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 Recognition 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.
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
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)