Back

EVS-EN IEC 60601-2-66:2020

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

General information

Valid from 15.04.2020
Base Documents
IEC 60601-2-66:2019; EN IEC 60601-2-66:2020
ICS Groups
11.180.15 Aids for deaf and hearing impaired people 17.140.50 Electroacoustics
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.04.2020
Main
EVS-EN IEC 60601-2-66:2020
05.01.2016
Main
EVS-EN 60601-2-66:2015
IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;
b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.

Required fields are indicated with *

*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 627 KB)

Related products

Amendment

EVS-EN 60601-2-37:2008/A1:2015

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Newest version Valid from 02.09.2015
Main

EVS-EN 60601-2-37:2008

Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Newest version Valid from 07.03.2008
Main

EVS-EN 61672-1:2013

Electroacoustics - Sound level meters -- Part 1: Specifications
Newest version Valid from 06.01.2014
Main

EVS-EN 50332-1:2013

Sound system equipment: Headphones and earphones associated with personal music players - Maximum sound pressure level measurement methodology -- Part 1: General method for "one package equipment"
Newest version Valid from 14.11.2013

Customers who bought this item also bought

Main

EVS-EN IEC 60118-13:2020

Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
Newest version Valid from 15.04.2020
Main + amendment

EVS-EN 60601-1-6:2010+A1:2015

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Valid from 15.11.2019
Amendment

ISO 8124-1:2018/Amd 1:2020

Safety of toys — Part 1: Safety aspects related to mechanical and physical properties — Amendment 1: Flying toys
Withdrawn from 15.09.2022
Amendment

ISO 8124-1:2018/Amd 2:2020

Safety of toys — Part 1: Safety aspects related to mechanical and physical properties — Amendment 2: Various
Withdrawn from 15.09.2022

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English