Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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

Scope:

IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard.

 

These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories.

 

This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.

 

This edition includes the following significant technical changes with respect to the previous edition:

•             refinement and additions to the defined terms;

•             additional separation of the requirements for HF surgical equipment and HF surgical accessories;

•             a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;

•             new requirements for devices that have or use a high current mode

Project need:

To maintain alignment with international requirements in the medical electrical equipment and update the current standard to meet new technology

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.