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IEC 80601-2-30 Ed. 1.0被替代

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

出版:International Electrotechnical Committee

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基本信息
标准编号: IEC 80601-2-30 Ed. 1.0
发布时间:2009/1/28 0:00:00
标准类别:Standard
出版单位:International Electrotechnical Committee
标准页数:108
标准简介

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.

本标准替代的旧标准

IEC 60601-2-30 Ed. 2.0

等同采用的国际标准

BS EN 80601-2-30:2010 - Identical

本标准修订后的版本

IEC 80601-2-30 Amd.1 Ed. 1.0 -