CAN/CSA C22.2 NO. 60601-1:14 + A2:22 (R2022) (CONSOLIDATED) ✓ Most Recent

CSA Preface 

This is consolidated edition 3.2 of CAN/CSA-C22.2 No. 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1 (edition 3:2005 consolidated with Amendment 1:2012 and Amendment 2:2020). It supersedes the second edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1 (adopted IEC 60601-1:2005). 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 "CAN/CSA-C22.2 No. 60601-1" throughout. Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence. 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 Care Technology and Systems. 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. Note: The Standards Council of Canada (SCC) has changed the method for identifying National Standards of Canada. The "CAN/" prefix that was previously added to the designation of a Standard has been replaced by the National Standard of Canada logo on the front cover. 

Scope and object 1.1 * 

Scope 

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. 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. 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. 

NOTE 1 See also 4.2. The IEC 60601 series does not apply to: – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or – medical gas pipeline systems covered by ISO 7396-1 [68]. NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. 1.2 Object The object of this standard is to specify general requirements and to serve as the basis for particular standards.