| 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 Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 6-405 |
| 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 |
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.
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.
| 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 |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers. Issued March 1993. |