标准摘要
[中文适用范围]： 本国际标准适用于临床体温计（临床温度计）的基本安全和主要性能，包括其附件。本标准规定了用于测量患者体温的电气临床体温计的一般和技术要求。本标准适用于所有用于测量患者体温的电气临床体温计。临床体温计可配备接口以容纳二次指示器、打印设备和其他辅助设备，从而形成医疗电气设备系统。本标准不适用于辅助设备。测量温度不是主要目的而是作为次要功能的医疗电气设备不在本标准的范围内。例如：Swan-Ganz 热稀释法测定心输出量不在本标准的范围内。包含温度探头的 Foley 导管在本标准的范围内。包含皮肤温度测量的患者加热医疗电气设备（如婴儿保温箱、加热毯、加热垫和加热床垫）不在本标准的范围内，除非它们指示本标准范围内的参考体位的温度。用于室内环境条件下对人群进行非侵入性发热体温筛查的医疗电气设备的要求在 IEC 80601-2-59:2008 中给出，此类设备不受本标准覆盖。如果条款或子条款专门适用于医疗电气设备或医疗电气设备系统，则该条款或子标题和内容将说明这一点。如果情况并非如此，则该条款或子条款适用于医疗电气设备和医疗电气设备系统（如适用）。本标准范围内的医疗电气设备或医疗电气设备系统在其预期生理功能中固有的危害，除 IEC 60601-1:2005 中的 7.2.13 和 8.4.1 外，本标准未包含具体要求。 [外文原描述]： ISO 80601-2-56:2009 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2009 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2009 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2009 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2009. Requirements for ME equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME equipment is not covered by ISO 80601-2-56:2009.
英文名称Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement