医用电气设备.第2-30部分:自动非入侵式血压测量计的基本安全性和基本性能的详细要求

[中文适用范围]： 除以下情况外，通用标准2的第1条适用@： 替换：80601国际标准的这一部分适用于自动血压计@的基本安全和基本性能@以下简称ME设备@，通过充气袖带@使用用于在不进行动脉穿刺的情况下非连续间接估计血压。注 1：无需动脉穿刺即可间接测定血压的设备并不直接测量血压。它仅估计血压。本文件规定了该 ME 设备及其附件@的基本安全和基本性能要求，包括测定准确性的要求。本文件涵盖用于间歇性间接估计血压（无需动脉穿刺）的自动电动 ME 设备，包括用于家庭医疗保健环境的血压监测仪。文件 ISO 81060 中规定了在不进行动脉穿刺的情况下间接估算血压的要求，带有电动压力传感器和/或显示器的 ME 设备，与听诊器或其他用于确定血压的手动方法（非自动血压计）结合使用-1 [2]。如果某条款或子条款专门旨在仅适用于 ME 设备@或仅适用于 ME 系统@，则该条款或子条款的标题和内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。除 IEC 60601-201.11 和 201.105.3.3@ 以及 7.2.13 和 8.4.1 之外，本文件中的具体要求不涵盖本文件范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。 1:2005。注 2 另见 IEC 60601-1:2005 和 IEC 60601-1:2005/AMD1:2012 的 4.2。 2 通用标准为IEC 60601-1:2005和IEC 60601-1:2005/AMD1:2012@医疗电气设备?C第1部分：基本安全和基本性能的通用要求。 [外文原描述]： 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.