CSA C22.2 NO. 60601-2-35:22

CSA Preface

This is the first edition of CSA C22.2 No. 60601-2-35, 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 60601-2-35 (second edition, 2020-09). It replaces the identically titled CAN/CSA-C22.2 No. 80601-2-35:12 (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. For brevity, this Standard will be referred to as “CSA C22.2 No. 60601-2-35” throughout.

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). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being. 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 of Canada by CSA Group.

Scope and object

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. 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.