CENELEC
Project
| 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 201.7.9.2 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. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2013-01-18 |
| Current Stage code deadline | 2013-08-06 |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | |
| Order Voucher |
Details
| 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 |
| Keywords | |
| Note | To be read in conjunction with EN 60601-1:2006 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
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 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN 60065:2002
corr. March 2006 corr. August 2007 A12:2011 A11:2008 EN 60118-7:2005 EN 60118-13:2011 EN 60601-1-11:2010 EN 60950-1:2006 corr. A12:2011 FprAE:2013 A11:2009 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.
