AS 60601.2.19:2018 PDF
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Medical electrical equipment, Part 2.19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 (ED 2.1), MOD)
Standards Australia , 06/29/2018
AS 60601.2.19:2018 PDF
The objective of this Standard is to specify safety requirements for infant incubators.
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.
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.
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