UNE-EN IEC 60601-2-35:2021

201.1 Scope, object and related standards

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

201.1.1 * Scope

Replacement:

This 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 International Standard.

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 apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled.

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.

NOTE See also 4.2 of the general standard.

This particular standard does not apply to:

HEATING DEVICES intended for physiotherapy;

radiant warmers; for information, see IEC 60601-2-21 [12]2;

incubators; for information, see IEC 60601-2-19 [10];

transport incubators, for information, see IEC 60601-2-20 [11];

cooling devices.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements, which minimize HAZARDS to PATIENTS, and OPERATORS for heating devices using BLANKETS, PADS or MATTRESSES and intended for heating in medical use and to specify tests for demonstrating compliance with these requirements.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2, IEC 60601-1-8 and IEC 60601-1-10 apply as modified in Articles 202, 208 and 210 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.