IEC 60601-2-34:2024适用于201.3.63中定义的有创血压监测设备（以下也称为ME设备）的基本安全性和基本性能。 本文件适用于专业医疗机构和紧急医疗服务环境中使用的有创血压监测设备。 本文件不适用于连接到圆顶的导管、导管针、鲁尔锁、丝锥和丝锥台。 本文件不适用于无创血压监测设备。 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，则该条款或子条款同时适用于ME设备和ME系统，如下所示:默认情况下，该条款或子条款适用于ME设备，并且仅当相应的安全措施或功能未完全集成到ME设备中而是作为ME系统的一部分实施时，该条款或子条款适用于ME系统。 IEC 60601-2-34:2024取消并取代2011年发布的IEC 60601-2-34第三版，构成技术修订。 与上一版相比，此版本包括以下重大技术变更: a)修订以与IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020以及新版本的抵押品标准及其修订保持一致； b)将范围扩展到紧急医疗服务环境； c)改变表201.101中的基本性能； d)改变了对入口保护的要求； e)增加了主要操作功能； f）删除附件BB报警图。

IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT.
This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME.
This document does not apply to non-invasive blood pressure monitoring equipment.
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 follows:
The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM.
IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto;
b) expansion of the scope to the emergency medical service environment;
c) changed essential performance in Table 201.101;
d) changed requirement for ingress protection;
e) added primary operating functions;
f) deleted Annex BB Alarm diagrams.