Draft Details

CSA Scope:

[Add the following paragraph]
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

IEC Scope:

Replacement: 

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, 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 PHOTOTHERAPY EQUIPMENT, 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 document 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; for information, see IEC 60601-2-19 [2]; 

– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [3]; 

– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [4].