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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 050 Date of Entry 09/17/2018 
FR Recognition Number 14-294
Standard
ANSI AAMI  ST40:2004/(R)2018
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
Scope/Abstract
This recommended practice provides guidelines for dry heat sterilization in health care facilities. It covers functional and physical design criteria for work areas; staff qualifications, education, and other personnel considerations; sterilization processing procedures; installation, care, and maintenance of table-top dry heat sterilizers; and quality control. Definitions, a bibliography, and annexes providing supplementary information are also included.
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
§880.6870 Sterilizer, Dry Heat Class 2 KMH
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, Issued March 1993.

Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, Issued September 1995.

ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers.


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 Contact
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@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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