范围:80601国际标准的本部分适用于自动血压计（以下简称ME设备）的基本安全和基本性能，该设备通过充气袖带，用于无需动脉穿刺的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不能直接测量血压。它只估计血压。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。 本文件涵盖了自动电动医用电气设备，用于在无需动脉穿刺的情况下间歇性间接估计血压，包括用于家庭医疗环境的血压监测器。文件ISO 81060-1[2]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。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IEC 60601-1:2005第201.11条和第201.105.3.3条以及第7.2.13条和第8.4.1条外，本文件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的固有危害。注2:另见IEC 60601-1:2005和IEC 60601-1:2005/AMD1:2012的4.2。目标:本特定标准的目的是为201.3.201中定义的自动血压计制定特定的基本安全和基本性能要求。

Scope:This part of the 80601 International Standard 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.NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.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 [2].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.NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.Object: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201.