标准摘要
[中文适用范围]： 本特定标准适用于侵入式血压监测设备（定义为 201.3.63 中的设备，以下简称 ME 设备）的基本安全和基本性能。本特定标准不适用于连接到圆顶的导管管、导管针、鲁尔锁、旋塞和旋塞台。本特定标准不适用于非侵入式血压监测设备。 [外文原描述]： IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.
英文名称Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment