• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • 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 049 Date of Entry 06/07/2018 
FR Recognition Number 6-405
Standard(Included in ASCA pilot)
IEC 80601-2-59 Edition 2.0 2017-09
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
Scope/Abstract
IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph.
This edition includes the following significant technical changes with respect to the previous edition:
a) updates of the normative references and the bibliography;
b) expansion of the applicability to pandemic infectious diseases in general.
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.

This standard is recognized on a scientific basis: Public health concern or hazard.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2910 Fever Monitoring Kit Class 2 PWW
§880.2910 Thermometer Kit Class 2 PXH
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
§880.2910 Thermometer, Exhaled Breath Class 2 OZK
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers. Issued March 1993.
FDA Technical Contact
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@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.
-
-