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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 034 Date of Recognition 01/30/2014 
FR Recognition Number 14-406
Standard
ANSI AAMI ST8:2013/(R)2018
Hospital steam sterilizers
Scope/Abstract
This standard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2 cubic feet).
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
§880.6880 Sterilizer, Steam Class 2 FLE
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.
FDA Technical Contact
 Ramesh K. Panguluri
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6303
  ramesh.panguluri@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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