DIN Standards Committee Health Technologies
DIN EN 60601-2-23
; VDE 0750-2-23:2016-08
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:2011); German version EN 60601-2-23:2015
Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane Partialdrucküberwachung (IEC 60601-2-23:2011); Deutsche Fassung EN 60601-2-23:2015
Overview
These special specifications establish specific requirements for basic safety, including essential performance characteristics, of transcutaneous partial pressure monitoring equipment. This applies to both stand-alone devices and devices that are part of a system. This standard applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. This standard does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). This standard is the adaptation to the new structure of DIN EN 60601-1:2007 and processing of the changed or new topics electromagnetic compatibility, usability and alarms, which are specified in the collatoral standards DIN EN 60601-1-2, DIN EN 60601-1-6 and DIN EN 60601-1-8. The committee responsible is Subcommittee DKE/UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
