标准摘要
[中文适用范围]： 、技术要求以及相应的测试方法，为相关产品的开发与认证提供了统一的技术依据。同时，标准还涉及了设备在不同使用条件下的性能表现，以保障其在实际应用中的有效性。此外，标准中对设备的标签、说明书及用户操作指南也提出了具体要求，以提升使用者的安全意识和操作规范性。 ***此介绍可能不准确，请注意参考原文。 [外文原描述]： IEC 80601-2-30:2009+A1:2013 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.This consolidated version consists of the first edition (2009) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers