Preface:

This is consolidated edition 2.1 of CAN/CSA-C22.2 No. 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, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-35 (edition 2:2009 consolidated with Amendment 1:2016). It supersedes the first edition, published in 2012 as CAN/CSA-C22.2 No. 80601-2-35 (adopted IEC 80601-2-35:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).

Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard by CSA Group.

Scope and object:

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.

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.