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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 6-385
Standard(Included in ASCA)
IEC  60601-2-19 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19:2009+A1:2016 specifies safety requirements for infantincubators. 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 1990 and its Amendment 1 (1996). This edition constitutes a technical revision. It was revised to structurally align with the third edition (2005) of IEC 60601-1. The contents of the corrigendum of February 2012 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FDA recognition of IEC 60601-2-19 Edition 2.1 2016-04 [Rec# 6-385] will be superseded by recognition of IEC 60601-2-19 Edition 3.0 2020-09 [Rec# 6-461]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-385] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-385] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5400 Incubator, Neonatal Class 2 FMZ
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Crystal Lewis
 Carolyn Dorgan
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.