scope:

Subclause 1.1 of the general standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMER, also referred to as ME EQUIPMENT . If a clause or subclause is specifically intended to be applicable to INFANT RADIANT WARMER 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 INFANT RADIANT WARMER and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of INFANT RADIANT WARMER 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.
NOTE See also 4.2 of the General Standard.
This particular standard specifies the safety requirements for INFANT RADIANT WARMERS as defined in 201.3.203 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 (ISO 14971) 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 standard can also be applied to INFANT RADIANT WARMER used for compensation or alleviation of disease, injury or disability.