DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 80601-2-30
; VDE 0750-2-30:2011-05
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Cor. :2010); German version EN 80601-2-30:2010
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten (IEC 80601-2-30:2009 + Cor. :2010); Deutsche Fassung EN 80601-2-30:2010
Overview
This standard applies to automated sphygmomanometers which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. They are electrically operated, periodically working instruments with indirect measurement. Instruments which indirectly measure blood pressure without arterial puncture with an electrically-powered pressure transducer and/or display used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are described in ISO 81060-1. This standard amends and supplements DIN EN 60601-1 (VDE 0750-1):2007-07. The responsible Committee is Subcommittee UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.