IEC 80601-2-30:2009 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 80601-2-30:2009

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：2009-01-28

标准范围

IEC 80601-2-30:2009适用于自动血压计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间歇性间接测量血压。它包括无需动脉穿刺的电动间歇性间接血压测量、带有自动血压估计方法的医用电气设备，包括用于家庭医疗环境的血压监测器。IEC 80601-2-30第一版取消并取代了1999年发布的IEC 60601-2-30第二版。本版本构成主要技术修订版，并与IEC 60601-1第三版保持一致。具体的技术变化包括:扩大范围，包括所有自动血压计，包括患者作为操作员的血压计、基本性能的识别、新的临床精度要求、额外的机械强度要求，以及禁止在气动系统中使用操作员可及的“鲁尔”接头。本副本包含2010年1月勘误表的内容。

IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.The contents of the corrigendum of January 2010 have been included in this copy.

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