DIN Standards Committee Heating and Ventilation Technology and their Safety
DIN EN 60601-2-34
; VDE 0750-2-34:2015-01
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (IEC 60601-2-34:2011); German version EN 60601-2-34:2014
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-Überwachungsgeräten (IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014
Overview
This particular standard applies to basic safety and essential performance characteristics of invasive blood pressure monitoring equipment as used in intensive care units or operating theatres. Invasive blood pressure monitoring equipment are used where higher accuracy during measurement is required. For this purpose, direct access (mostly arterial) to the patient is required. 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, that is devices equipped with blood pressure cuffs and which are cyclically pneumatically inflated or deflated. The responsible committee is Subcommittee DKE/UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
