DIN EN IEC 60601-2-20
; VDE 0750-2-20:2024-10
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2020 + AMD1:2023); German version EN IEC 60601-2-20:2020 + A1:2023
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Transportinkubatoren (IEC 60601-2-20:2020 + AMD1:2023); Deutsche Fassung EN IEC 60601-2-20:2020 + A1:2023
Overview
This document applies to the basic safety and essential performance of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - infant incubators which are not INFANT TRANSPORT INCUBATORS; for information see IEC 60601-2-19; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; – INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50. The standard differs from DIN EN IEC 60601-2-20 (VDE 0750-2-20):2021-08 as follows: a) the Clause "Normative references" has been revised and supplemented; b) individual terms and definitions have been revised and the reference to IEC 60601-1:2005/AMD2:2020 has been added; c) The sound level values have been adapted in the subclause "Sound level of audible alarms"; d) the accuracy value has been adjusted in the clause "Accuracy of the transport incubator temperature display"; e) the reference to IEC 60601-1-2:2014/AMD1:2020 has been added in the Clauses "Normative references" and "Electromagnetic disturbances - Requirements and tests" as well as in the subclauses "Supplementary standards" and "Immunity test level"; f) a subclause 212.4.1 "Additional requirements for power supply networks for ME devices and ME systems" has been added; g) a subclause 212.10.1 "Additional requirements for the mechanical strength of ME devices intended for use in emergency situations" has been added; h) a clause 212.11 "Additional requirements for the electromagnetic compatibility of ME devices and ME systems" has been added; i) Annex AA has been revised and supplemented. This specific standard specifies requirements for the safety of INFANT TRANSPORT INCUBATORS.
