Medical electrical equipment – Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

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. 60601-2-76
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
ICS code(s):
11.040
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

201.1 Scope, object and related standards 

Clause 1 of the general standard1 applies, except as follows: 

201.1.1 Scope 

Replacement: 

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW 

ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT. 

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. 

NOTE See also 4.2 of the general standard. 

Project need:

This proposed New Standard is being developed at the request of Z290 and C234 Technical Committees. It will provide the industry with the latest requirements for the safety testing of medical devices. This will meet the strategic needs of the following key interests: a) ensuring that the latest innovative/technology/safety features are available for users, b) addressing needs of regulators by providing suitable requirements; and c) supporting certification bodies.

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.