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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 051 Date of Entry 01/14/2019 
FR Recognition Number 14-518
ANSI AAMI ST55:2016 Table-top steam sterilizers
Scope/Abstract
This standard establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 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.
Transition Period
FDA recognition ANSI AAMI ST55:2010/(R)2014 [Rec# 14-311] will be superseded by recognition of ST55:2016 [Rec# 14-518]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-311] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 14-311] will not be accepted.
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
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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