Medical electrical equipment — Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Designation Number:
CSA C22.2 NO. 60601-2-63
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.50
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

C22.2 No. 60601-2-63:2012+A1:2017+A2:2021 applies to the basic safety and essential performance of 
dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems 
containing such ME equipment. This particular standard has been prepared to provide, based on C22.2 No. 
60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for 
dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated 
to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray 
equipment. Components and their functions are addressed as far as necessary. The scope of this standard is 
restricted to X-ray equipment where: 
- the x-ray tube assembly contains the high-voltage transformer assembly; and 
- the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and 
the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during 
intended use. 

Project need:

To maintain alignment with international requirements (new edition of adoption, new adopted standard, new amendment of an adopted standard, etc.) This proposed New Amendments 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.