CAN/CSA-C22.2 NO. 60601-2-33:12 (R2021):2012 Edition
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Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Published By | Publication Date | Number of Pages |
CSA | 2012 | 251 |
CSA Preface
This is the third edition of CAN/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 without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-33 (third edition, 2010-03). It supersedes the previous edition published in 2004 as CAN/CSA-C22.2 No. 60601-2-33 (adopted IEC 60601-2-33:2002). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (adopted CEI/IEC Standard 60601-1:2005, with Canadian deviations).
This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.
Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.
This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
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.
The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.