CAN/CSA C22.2 NO. 60601-1-2:16 (R2021) + A1:22 (CONSOLIDATED) PDF

CSA Preface 

This is consolidated edition 4.1 of CSA C22.2 No. 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests , which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-2 (edition 4:2014 consolidated with Amendment 1:2020). It supersedes the third edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (adopted IEC 60601-1-2:2007). 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. 60601-1-2" 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). 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. 

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. This collateral standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS. BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT and ME SYSTEMS. 

1.2 Object The object of this collateral standard is to specify general requirements and tests for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES and for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS. They are in addition to the requirements of the general standard and serve as the basis for particular standards.