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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 14-293
Standard
ANSI AAMI ST50:2004/(R)2018
Dry heat (heated air) sterilizers
Scope/Abstract
This standard establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other 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.
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 ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.
FDA Technical Contact
 Elaine Mayhall
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6301
  Elaine.Mayhall@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
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