Draft Details

Draft Scope/Description:

Note: This second IEC edition cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016.

201.1 Scope, object and related standards

Clause 1 of the general standard1 applies, except as follows:

201.1.1 * Scope

Replacement:

This part of 60601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.

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.

If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then 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 document does not apply to:

– HEATING DEVICES intended for physiotherapy;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
– cooling devices.

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