DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 80601-2-55
; VDE 0750-2-55:2012-03
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011); German version EN ISO 80601-2-55:2011
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 80601-2-55:2011); Deutsche Fassung EN ISO 80601-2-55:2011
Overview
This product standard from the DIN EN 60601-1 (VDE 0750-1) series describes the safety requirements for respiratory gas monitors (RGM), intended for continuous operation for use with a patient. These safety requirements include requirements for anaesthetic gas, carbon dioxide and oxygen monitoring. An RGM can be either standalone ME equipment or integrated into other equipment, for example, an anaesthetic workstation or a ventilator. RGM intended for use with flammable anaesthetic agents are outside the scope of this International Standard. The responsible committee is Subcommittee UK 812.3 "Inhalationsnarkose- und Beatmungsgeräte" ("Inhalation anaesthesia and respiratory equipment") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/UK 812.3 - Inhalationsnarkose- und Beatmungsgeräte
Responsible european committee
CEN/TC 215 - Respiratory and anaesthetic equipment
