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