Draft Details

CSA Scope

201.1.1 Scope

[Add the following paragraph]

This Standard covers ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

IEC Scope

Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020 applies, except as follows: 

201.1.1 Scope 

Replacement: 

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.

 
NOTE 1 Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this document. 

NOTE 2 ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT is intended for diagnostic and monitoring applications. 

NOTE 3 If the ME EQUIPMENT supports both ELECTROMYOGRAPHY and EVOKED RESPONSE STIMULATION, clauses for electrical, auditory, and visual stimulators are applicable. In case the equipment supports ELECTROMYOGRAPHY, but not EVOKED RESPONSE STIMULATION, clauses concerning solely requirements for stimulators are NOT within the scope of this document. 

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to MESYSTEMS, as relevant. 

The following ME EQUIPMENT are excluded: 

- ME EQUIPMENT intended for therapeutic application;

- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).