SR EN IEC 60601-2-34:2025

Aparate electromedicale. Partea 2-34: Cerințe particulare de securitate de bază și performanțe esențiale pentru aparate de monitorizare invazivă a presiunii sanguine

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

501,50 Lei

Status : In vigoare
Data aprobării : 31.01.2025
Număr de pagini : 135
ICS : 11.040.55 Echipament pentru diagnosticare
Comitet tehnic : 22 - Echipamente electromedicale

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