Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

064

Date of Entry 05/26/2025

FR Recognition Number

17-20

Standard

(Included in ASCA)

IEC 60601-2-40 Third edition 2024-12
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Scope/Abstract

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 ME SYSTEMS, 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).

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§882.1320	Electrode, Cutaneous	Class 2	GXY
§890.1375	Electromyograph, Diagnostic	Class 2	IKN
§890.1375	Device, Muscle Monitoring	Class 2	KZM
§890.1375	Exercise Equipment, Powered, Emg-Triggered	Class 2	OAL
§890.1385	Electrode, Needle, Diagnostic Electromyograph	Class 2	IKT
§890.1850	Stimulator, Muscle, Diagnostic	Class 2	ISB
§890.3450	Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography	Class 2	PAE

Relevant FDA Guidance and/or Supportive Publications*

H. Tankisi et al. (2020) Standards of instrumentation of EMG. Clinical Neurophysiology, 131(1) 243-258. doi: 10.1016/j.clinph.2019.07.025

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Zach McKinney

CDRH/OPEQ/OHTV/DHTVB/

301-796-4328

zachary.mckinney@fda.hhs.gov

Kim Kontson

CDRH/OSEL/DBP

301-796-4990

Kimberly.Kontson@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission