1.1 本规范涵盖用于通过检测测量对象和传感器之间的热辐射强度来间歇性测量和监测患者温度的电子仪器。 1.2 本规范旨在通过测量耳道的热辐射来评估受试者的体内温度。还提供了皮肤的非接触温度测量的性能要求。 1.3 本规范规定了实验室准确度的限制，并要求确定和披露所涵盖仪器的临床准确度。 1.4 建立了各种环境条件下的性能和储存极限、标签要求和测试程序。 注1: 有关电气安全，请咨询美国保险商实验室标准。 2. 注2: 有关电磁辐射要求和测试，请参阅CISPR 11:1990工业、科学和医疗（ISM）射频设备电磁干扰特性测量方法列表。 3. 1.5 以国际单位制表示的数量值应视为标准。括号中的数量值不采用国际单位制，是可选的。 1.6 以下预防性警告仅适用于测试方法部分，第节 6. ，本规范: 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。

1.1 This specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. 1.2 The specification addresses assessing subject’s body internal temperature through measurement of thermal emission from the ear canal. Performance requirements for noncontact temperature measurement of skin are also provided. 1.3 The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments. 1.4 Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are established. Note 1: For electrical safety, consult Underwriters Laboratory Standards. 2 Note 2: For electromagnetic emission requirements and tests, refer to CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment. 3 1.5 The values of quantities stated in SI units are to be regarded as the standard. The values of quantities in parentheses are not in SI and are optional. 1.6 The following precautionary caveat pertains only to the test method portion, Section 6 , of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.