Preface:

This is consolidated edition 1.2 of CAN/CSA-C22.2 No. 60601-2-54, Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-54 (edition 1:2009 consolidated with Amendment 1:2015 and Amendment 2:2018). It replaces CAN/CSA-C22.2 No. 60601-2-7:01 (adopted IEC 60601-2-7:1998) and CAN/CSA-C22.2 No. 601.2.32:98 (adopted IEC 601-2-32:1994). 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. 60601-1:14, 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 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:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard.

ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators.

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.

Object:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY.