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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 6-386
Standard(Included in ASCA pilot)
IEC 60601-2-20 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-20:2009/A1:2016
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)]
Scope/Abstract
IEC 60601-2-20:2009+A1:2016 specifies safety requirements for infanttransport incubators. 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 of IEC 60601-2-20 published in 1990 and its Amendment 1 (1996). This edition constitutes a technical revision. This edition of IEC 60601-2-20 was revised to structurally align with the 2005 edition of IEC 60601-1. The contents of the corrigenda of February 2012 and February 2013 have been included in this copy. This consolidated version consists of the second edition (2009) and its amendment 1 (2016).
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FDA recognition of IEC 60601-2-20 Edition 2.1 2016-04 [Rec# 6-386] will be superseded by recognition of IEC 60601-2-20 Edition 3.0 2020-09 [Rec# 6-462]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-386] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-386] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5410 Incubator, Neonatal Transport Class 2 FPL
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and FDA Reviewers/Staff - Neonatal and Neonatal Transport Incubators - Premarket Notifications, Issued September 1998.
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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