Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Scope/Abstract
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FDA recognition of IEC 60601-2-19 Edition 2.1 2016-04 [Rec# 6-385] will be superseded by recognition of IEC 60601-2-19 Edition 3.0 2020-09 [Rec# 6-461].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
  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.
-
-