DIN EN IEC 60601-2-21
; VDE 0750-2-21:2024-10
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020 + AMD1:2023); German version EN IEC 60601-2-21:2021 + A1:2023
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC 60601-2-21:2020 + AMD1:2023); Deutsche Fassung EN IEC 60601-2-21:2021 + A1:2023
Overview
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS. These particular requirements specify safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with specific clauses, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the MEDICAL ELECTRICAL EQUIPMENT. These particular requirements do not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS, for information see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. The standard differs from DIN EN IEC 60601-2-21 (VDE 0750-2-21):2022-11 as follows: a) the Clause "Normative references" has been revised and supplemented. Individual terms and definitions have been revised and the reference to IEC 60601-1:2005/AMD2:2020 has been added; b) a change has been made to the table in the subclause "Additional requirements for essential performance characteristics"; c) additions have been made to the subclause "Warnings and safety notes"; d) The sound level values have been adapted in the subclause "Sound level of audible alarms"; 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 subclause "Supplementary standards"; f) Annex AA has been revised and supplemented; g) addition to and revision of the Clause "Bibliography".
