CAN/CSA C22.2 NO. 60601-2-33:23 PDF

CSA Preface 

This is the fourth edition of CSA C22.2 No. 60601-2-33, Medical electrical equipment — Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-33 (fourth edition, 2022-08). It supersedes the previous edition, published in 2012 as CAN/CSA-C22.2 No. 60601-2-33 (adopted IEC 60601-2-33:2010). 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. 60601-2-33" 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 Standard 60601-1:2005, edition 3.2, 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 applies, except as follows: 

201.1.1 Scope Replacement: This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS. This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant. This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

201.1.2 Object Replacement: 

The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MR EQUIPMENT to provide protection for the PATIENT and the MR WORKER. NOTE This document presumes that the MR WORKERs are screened, trained and instructed in their duties.