Clause 1 of the general standard applies, except as follows:
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209 of this standard, 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
This particular standard specifies safety requirements for INFANT 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 80601-2-35;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
– INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50
BS EN 60601-2-19:2009 history
1970BS EN 60601-2-19:2009+A1:2016 Medical electrical equipment — Part 2-19 : Particular requirements for the basic safety and essential performance of infant incubators
2009BS EN 60601-2-19:2009+A11:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators
2009BS EN 60601-2-19:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators