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

80601-2-59 Edition 2.0 2017-09

Standard Organization: IEC

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

Recognition NumberGeneral Plastic Surgery/General Hospital
Recognition Date2018-06-07
Recognition List049
Recognition Number6-405
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG General Plastic Surgery/General Hospital
FDA Tech  Quanzeng Wang   FDA/OMPT/CDRH/OSEL/DBP/   301-796-2612   quanzeng.wang@fda.hhs.gov

Rationale:

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.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§876.4680 Dislodger, Stone, Basket, Ureteral, Metal Class 2 FFL
§880.2910 Fever Monitoring Kit Class 2 PWW
§880.2910 Thermometer Kit Class 2 PXH
§880.2910 Thermometer, Exhaled Breath Class 2 OZK

FDA Guidance:

Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers. Issued March 1993.


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