Appareils électromédicaux - Partie 2-59: Exigences particulières pour la sécurité de base et les performances essentielles des imageurs thermiques pour le dépistage des humains fébriles

201.1 Scope, object and related standards

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 humans under indoor environmental conditions, hereafter referred to

as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for

the SCREENING THERMOGRAPH.

NOTE A SCREENING THERMOGRAPH is intended for screening and detection of human subjects with SKIN

TEMPERATURES elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent

temperature measurement using a clinical thermometer (see IEC 80601-2-56).

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.