DS/EN IEC 60601-2-20:2020/A1:2023

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

This part of IEC 60601 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.*HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS*within the scope of this document are not covered by specific requirements in this document,*except in 7.2.13 and 8.4.1 of the general standard.*NOTE – See also 4.2 of the general standard.*This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS, but*alternate methods of compliance with a specific clause, 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 device.*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 [1]2;*– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see*IEC 60601-2-19 [2];*– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];*– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].