DANSK DSF/FPREN IEC 60601-2-34 PDF

This particular standard 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 particular standard does not apply to catheter tubing, catheter needles, L uer locks, taps and tap tables that connect to the DOME. This particular standard 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. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.