Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
C22.2 NO. 60601-2-65
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.55
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

C22.2 No. 60601-2-65:2012+A1:2017+A2:2021 applies to the basic safety and essential performance of 
dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray 
equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral 
X-ray equipment is excluded from the scope of this standard. 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 intra-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 intra-oral X-ray equipment. Components and their functions are addressed as far as 
necessary. 

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.