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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 6-388
Standard(Included in ASCA pilot)
IEC 60601-2-21 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-21:2009/A1:2016
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
Scope/Abstract
IEC 60601-2-21:2009+A1:2016 specifies the safety requirements for infant radiant warmers. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1994 and its Amendment 1 (1996). This edition constitutes a technical revision. This edition of IEC 60601-2-21 was revised to structurally align with the 2005 edition of IEC 60601-1. The contents of the corrigendum of February 2013 have been included in this copy. This consolidated version consists of the second edition (2009) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.
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FDA recognition of IEC 60601-2-21 Edition 2.1 2016-04 [Rec# 6-388] will be superseded by recognition of IEC 60601-2-21 Edition 3.0 2020-09 [Rec# 6-463]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-388] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-388] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5130 Warmer, Infant Radiant Class 2 FMT
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contacts
 Crystal Lewis
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6116
  Crystal.Lewis@fda.hhs.gov
 Carolyn Dorgan
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC
  240-402-1656
  Carolyn.Dorgan@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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