DANSK DSF/FPREN IEC 60601-2-20 PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME SYSTEMS only, the title and content of that clause or subclause will case, the clause or subclause applies both to ME EQUIPMENT and to HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this standard are not covered by specific requirements 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 TRANSPORT alternate methods of compliance with a specific clause by demonstrating not be judged as non compliant if the MANUFACTURER has demonstrated MANAGEMENT FILE that the RISK presented by the HAZARD has acceptable level when weighed against the benefit of treatment from This particular standard does not apply to: – devices supplying heat via BLANKETS, PADS or MATTRESSES in medical see IEC 80601-2-35 [1]1); – INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; IEC 60601-2-19 [2]; – INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3]; – INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].