IEC 80601-2-30:2018适用于自动血压计（以下简称ME设备）的基本安全性和基本性能，该设备通过充气式袖带，用于非连续间接估计血压，无需动脉穿刺。本文件规定了医用电气设备及其附件的基本安全和基本性能要求，包括测定准确性要求。本文件涵盖自动变速器- 电动医用电气设备，用于间歇性间接估计血压，无需动脉穿刺，包括用于家庭医疗环境的血压监测器。ISO 81060文件规定了无需动脉穿刺间接估计血压的要求，该设备配有电动压力传感器和/或显示器，与听诊器或其他手动血压测定方法（非自动血压计）结合使用- 1.如果某一条款或子条款明确规定仅适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容应如此说明。如果情况并非如此，则本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。除201.11和201.105.3.3以及201.105.3.7外，本文件中的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能所固有的危险。 IEC 60601-1:2005的2.13和8.4.1。本第二版取消并取代2009年出版的第一版和修订本1:2013。本版为技术修订版。与上一版相比，本版包括以下重大技术变更: a） 符合IEC 60601-1:2005/AMD1:2012和IEC 60601-1-8:2006/AMD1:2012，以及IEC 60601-1-2:2014和IEC 60601-1-11:2015； b） 参考IEC 60601-1-10:2007和IEC 60601-1-12； c） 更换操作员可触及的袖口- 血压计连接器从与ISO 594系列不兼容到与ISO 80369系列兼容； d） 增加了对公共自用血压计的额外要求； e） 添加了主要操作功能的列表。

IEC 80601-2-30:2018 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for non continuous indirect estimation of the blood pressure without arterial puncture. This document specifies requirements for the basic safety and essential performance for this ME equipment and its accessories, including the requirements for the accuracy of a determination. This document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. Requirements for indirect estimation of the blood pressure without arterial puncture ME equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012, and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015; b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12; c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series; d) added additional requirements for public self-use sphygmomanometers; e) added a list of primary operating functions.