Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

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. 60601-2-10:14
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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

201.1.1 * Scope

Replacement:

This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine, hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).

Note: A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.

The following ME EQUIPMENT is excluded:

ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes

ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME EQUIPMENT)

ME EQUIPMENT intended for neurological research

external cardiac pacemakers (see IEC 60601-2-31)

ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40)

ME EQUIPMENT intended for electromyography (see IEC 60601-2-40)

ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4)

Project need:

To review the Standard within the required 5 year period.

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.