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ANSI/IEC.80601.2.35
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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This International Standard applies to the BASIC SAFETY andESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS orMATTRESSES in medical use, also referred to as ME EQUIPMENT.HEATING DEVICES intended to prewarm a bed are included in the scopeof this International Standard.

If a clause or subclause is specifically intended to beapplicable to ME EQUIPMENT only, or to ME SYSTEMS only, the titleand content of that clause or subclause will say so. If that is notthe case, the clause or subclause applies both to ME EQUIPMENT andto ME SYSTEMS, as relevant.

If a clause or subclause is specifically intended to apply to aspecifically defined type of ME EQUIPMENT, as is the case withFORCED AIR DEVICES, then the clause or subclause is entitled assuch. Clauses or subclauses that apply to all types of ME EQUIPMENTwithin the scope of this standard are not specificallyentitled.

HAZARDS inherent in the intended physiological function of MEEQUIPMENT or ME SYSTEMS within the scope of this standard are notcovered by specific requirements in this standard except in 7.2.13and 8.4.1 of the general standard.