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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 6-387
Standard(Included in ASCA)
IEC  60601-2-50 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-50:2009/A1:2016
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
Scope/Abstract
IEC 60601-2-50:2009+A1:2016 establishes particular basic safety and essential performance requirements for infant phototherapy equipment, which reduce the safety hazards to patients and operators as much as possible, and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision. The main purpose of this new edition is to provide consistency with the third edition of the general standard. This edition further provides consistency with the four other particular standards related to pediatric equipment for which the committee is responsible. The contents of the corrigendum of August 2010 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FDA recognition of IEC 60601-2-50 Edition 2.1 2016-04 [Rec# 6-387] will be superseded by recognition of IEC 60601-2-50 Edition 3.0 2020-09 [Rec# 6-450]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-387] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-387] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5700 Unit, Neonatal Phototherapy Class 2 LBI
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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 Contact
 Sajjad Syed
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6295
  sajjad.syed@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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