scope:

Subclause 1.1 of the general standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, 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.
NOTE: See also 4.2 of the general standard.
This Particular Standard specifies safety requirements for ME EQUIPMENT or ME SYSTEMS, as
defined in 201.3.203 of this standard, 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 (EN 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 PHOTOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability.