GB/T 21416-2008 in English

《GB/T 21416-2008医用电子体温计》由TC10（全国医用电器标准化技术委员会）归口，TC10SC5（全国医用电器标准化技术委员会医用电子仪器分会）执行，主管部门为国家药品监督管理局。
医用电子体温计是一种间歇监控患者体温的电子仪器。为了规范产品的技术特性，保证产品的有效性和安全性，特制定本标准作为生产和质量监控的依据。本标准规定了医用电子体温计的术语和定义、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存；适用于间歇监控人体体温的数字显示医用电子体温计，该体温计供医疗部门或家庭作测量人体体温使用，可用于人体的腋下、口腔、肛门等不同部位。
本标准的技术要求非等效采用ＥＮ１１１２-００《间歇测量患者体温的医用电子体温计标准规范》。

Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of medical electronic thermometers. This standard applies to digital medical electronic thermometers for intermittent monitoring of human body temperature (hereinafter referred to as thermometers), which are used in medical departments or households to measure human body temperature, and can be used in different parts of the human body such as armpits, mouth, and anus.