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DIN EN IEC 60601-2-21 VDE 0750-2-21 Berichtigung 1:2025-07

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; Corrigendum 1
Class/Status: Standard, valid
Released: 2025-07
VDE Art. No.: 0701615

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
RADIANT WARMERS.
This particular standard does 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.