DIN EN ISO 11197:2016-08

This standard contains safety-related specifications for medical supply units used to supply medical devices with energy and/or gaseous or liquid medical media. The standard contains in particular requirements for protection against electrical hazards, for fire prevention and for the design and requirements of the gas or liquid technical equipment. Compared to the last edition, the structure of the present draft has been adapted due to the revision of the basic standard IEC 60601-1:2005 and additionally adapted to the state of the art. The schematic representations for the structure of medical supply units have been further developed to improve readability. Manufacturer-specific requirements for the final inspection have been summarized and supplemented in a separate Annex. The committee responsible is Subcommittee UK 812.8 "Medizinische Versorgungseinheiten" ("Medical gas supply systems") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.