医用电气设备第2-30部分:自动无创血压计基本安全和基本性能的特殊要求

[中文适用范围]： 本部分国际标准的适用对象为通过充气袖带用于间歇性、非连续性间接估算血压（无动脉穿刺）的自动化非侵入式血压计（以下简称医用电气设备）。本文件规定了此类医用电气设备及其附件的基本安全和主要性能要求，包括测量准确度的要求。本文件涵盖用于间歇性、非连续性间接估算血压（无动脉穿刺）的自动电动医用电气设备，包括用于家庭医疗环境的血压监测仪。 本文件不适用于使用电动血压传感器和/或显示器，并配合听诊器或其他手动方法测量血压（非自动化血压计）的间接估算血压的医用电气设备，相关要求见ISO 81060-1标准。 本文件不包括旨在生理功能固有的危害，除非在201.11、201.105.3.3以及IEC 60601-1:2005的7.2.13和8.4.1中另有规定。 [外文原描述]： IEC 80601-2-30:2018 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. 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.