本标准规定了机械式血压计及其附件的要求 通过充气袖口用于非侵入性治疗的附件 测量血压。本标准还规定了 这些仪器和设备的安全性、基本性能、有效性和标签 其附件，包括确定其精度的试验方法 测量。本标准涵盖无创血压测量设备 与机械压力传感元件和显示器配合使用 听诊器或其他手动检测科罗特科夫声音的方法。

This standard specifies requirements for mechanical sphygmomanometers and their accessories that, by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labeling, for these instruments and their accessories, including test methods to determine the accuracy of their measurements. The standard covers non-invasive blood pressure measuring devices with a mechanical pressure sensing element and display used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds.