International Standards and Conformity Assessment for all electrical, electronic and related technologies





Reference EN 60601-2-66:2013
Title Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
Project Number 23596
Abstract/Scope IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to: - cochlear implants or other implanted hearing instruments; - bone conduction hearing instruments; - educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.); - the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies; - audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1; - assisted hearing instrument systems using infra-red or radio; - and the sound generating function of a tinnitus masker.


Current Stage code 6060
Current Stage code date 2013-01-18
Current Stage code deadline 2013-08-06
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Order Voucher  


IEC Technical Body IEC/TC 29
Reference Document IEC 60601-2-66:2012 (EQV)
ICS 11.180.15 - Aids for deaf and hearing impaired people
17.140.50 - Electroacoustics
Note To be read in conjunction with EN 60601-1:2006
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2013-01-18 2013-08-06 export to doc file  EN  FR  DE
5099 2012-11-06 2012-12-04  
5060 2012-09-10 2012-10-01 export to doc file  EN
5020 2012-06-29 2012-09-07  
5060 2011-11-07 2011-11-28 export to doc file  EN
5020 2011-06-03 2011-11-04  
1090 2011-05-31 2011-06-03  

Implementation Dates

date of Ratification (DOR) (1) 2012-11-06
date of Availability (DAV) (2) 2013-01-18
date of Announcement (DOA) (3) 2013-02-06
date of Publication (DOP) (4) 2013-08-06
date of Withdrawal (DOW) (5) 2015-11-06


Superseded by  
Normative reference (6) EN 60065:2002
corr. March 2006
corr. August 2007
EN 60118-7:2005
EN 60118-13:2011
EN 60601-1-11:2010
EN 60950-1:2006
EN 62304:2006
corr. November 2008
EN 62366:2008

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved

(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat

(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level

(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn

(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.