Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
|Publication Date:||1 May 2011|
|ICS Code (Diagnostic equipment):||11.040.55|
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter referred to as ME EQUIPMENT.
This particular standard does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME.
This particular standard does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT.