Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

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. 60601-2-41
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.55
11.040.99
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Replacement:

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.

This particular standard does not apply to

- headlights;
- endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
- luminaires used in dentistry, which are covered by ISO 9680;
- luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
- luminaires dedicated to therapeutic purposes;
- special purpose lights with different conditions of use such as UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
- lights connected to surgical instruments;
- luminaires of an emergency lighting, which are covered by IEC 60598-2-22.

NOTE See also 4.2 of the general standard.

Project need:

This proposed New Edition 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.