UNE EN IEC 80601-2-59:2019
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in November of 2019.)
Equipos electromédicos. Parte 2-59: Requisitos particulares para la seguridad básica y funcionamiento esencial de los termógrafos de exploración para la detección de la temperatura humana febril. (Ratificada por la Asociación Española de Normalización en noviembre de 2019.)
| Standard number: | UNE EN IEC 80601-2-59:2019 |
| Pages: | 50 |
| Released: | 2019-11-01 |
| Status: | Standard |
UNE EN IEC 80601-2-59:2019
Clause 1 of the general standard2 applies, except as follows: 201.1.1 * Scope Replacement: This International Standard 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 International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE 1 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]). NOTE 2 Such equipment is commonly referred to as an infrared camera. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SCREENING THERMOGRAPHS as defined in 201.3.209.
