This is the second edition of CAN/CSA-C22.2 No. 60601-2-19. 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. 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 [3]2); INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2]; INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1]; INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4].

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.208, which minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the requirements can be verified.