IEC 80601-2-30:2018 医疗电气设备 - 第2-30部分:自动化非侵入性血压计的基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-30:2018

中文名称：医疗电气设备 - 第2-30部分:自动化非侵入性血压计的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

发布日期：2018-03-22

标准范围

新的！IEC 80601-2-30:2018作为IEC 80601-2-30:2018 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。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，自动血压计通过充气袖带用于无需动脉穿刺的非连续间接血压估计。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，包括测定准确性要求。本文件涵盖了用于间歇性、间接估计血压而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计。文件ISO 81060-1规定了在没有动脉穿刺ME设备的情况下间接估计血压的要求，该设备带有电动压力传感器和/或显示器，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。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。本文件范围内的ME设备或ME系统预期生理功能中固有的危害不在本文件中的具体要求范围内，201除外。11和201.105.3.3，以及IEC 60601-1:20 05的7.2.13和8.4.1。本第二版取消并取代了2009年出版的第一版和修正案1:20 13。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)与IEC 60601-1:20 05/AMD1:2012和IEC 60601-1-8:20 06/AMD1:2012以及IEC 60601-1-2:20 14和IEC 60601-1-11:20 15一致；b)参考IEC 60601-1-10:20 07和IEC 60601-1-12；c)将操作者可接近的袖带血压计连接器从不与ISO 594系列兼容改变为与ISO 80369系列兼容；d)增加了公众自用血压计的附加要求；e)增加了主要操作功能列表。

NEW!IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

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