标准摘要
[中文适用范围]: IEC 80601 的本文部分适用于旨在在受控环境条件下用于人类发热筛查的非侵入式筛查热像仪(以下简称医疗电气设备)的基本安全和关键性能。本文档规定了筛查热像仪的实验室表征测试限值。筛查热像仪旨在对人类受试者进行筛查,并检测高于正常值的皮肤温度。高于正常值的皮肤温度需要使用临床温度计进行后续测量(参见 ISO 80601-2-56)。此类设备的主要部分通常被称为红外相机。 [外文原描述]: IEC 80601-2-59:2017+AMD1.2023 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.
英文名称Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening