Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CSA-C22.2 No. 60601-2-54
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.50
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Replacement: 
This document 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 document. 

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 document. The scope of this document 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. 

Project need:

To maintain alignment with international requirements (new edition of adoption, new adopted standard, new amendment of an adopted standard, etc.) The proposed New Edition/ New Amendment are being developed at the request of Technical Committees. It will provide the industry with the latest requirements for the safety testing of medical devices.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.