DIN EN 62353:2015-10

The German edition of IEC 62353 (second edition) applies to testing of medical electrical equipment and medical electrical systems or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 (for example, the IEC 60335 series of standards and IEC 61010) these requirements may be used taking into account the relevant safety standards for the manufacture of such equipment. In this edition, the recurrent testing of medical electrical systems (for example, combination of a medical device with a connected printer) is also presented. The assessment of the electrical integration of medical electrical devices into an information technology network is considered. The responsible committee is DKE/K 811 "Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung" ("Common aspects of electrical equipment used in medical practice") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.