Medical Electrical Equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

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. 80601-2-78
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This Standard applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS following an IMPAIRMENT.

This particular standard does not apply to:

  • (external limb) prosthetic devices (use: ISO 22523)
  • Electric wheelchairs (use: ISO 7176 series)
  • Diagnostic imaging equipment (e.g. MRI, use: IEC 60601-2-33)
  • Personal care robots (use: ISO 13482)

Project need:

To align Canadian requirements with those of international standards in the medical equipment and medical equipment systems related to medical robots, and to support the innovation of new technologies.

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.