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  • BSI
    BS EN IEC 60601-2-34:2024 Medical electrical equipment - Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    Edition: 2025
    $516.89
    / user per year

Description of BS EN IEC 60601-2-34:2024 2025

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.

Standard NumberBS EN IEC 60601-2-34:2024
TitleMedical electrical equipment - Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
StatusDefinitive
Publication Date2025-01-23
ReplacesBS EN 60601-2-34:2014
Identical National Standard OfEN 60601-2-34 Amd.1 Ed.3.0, IEC 60601-2-34 Amd.1 Ed.3.0
DescriptorsBlood pressure, Clinical investigation instruments, Safety measures, Electronic equipment and components, Electrical safety, Performance, Electrical medical equipment, Medical equipment, Safety engineering, Cardiology, Sphygmomanometers, Electrical equipment, Pressure measurement (fluids)
ICS11.040.55 Diagnostic equipment
CommitteeCH/62/4
ISBN978 0 539 17214 0
PublisherBSI
Pages68

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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