Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances — Requirements and tests

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. 60601-1-2:16
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

1.1 *
Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS.

BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT and ME SYSTEMS.

1.2
Object

The object of this collateral standard is to specify general requirements and tests for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES and for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS. They are in addition to the requirements of the general standard and serve as the basis for particular standards.

Project need:

To align Canadian requirements with those of international standards in the medical electrical equipment subject area and update the current standard to user experience/feedback/new technology. This proposed New Amendment is being developed at the request of Canadian mirror committee to IEC TC 62 and the industry. It will provide the industry with an update to the current standard to meet the requirements for advancement in 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.