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Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
| 분야 | TC 29 : Electroacoustics |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 |
17.140.50 : 전자 음향
11.180.15 : 청각장애인을 위한 보조기구 |
| 페이지수 | 86 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-66:2019 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems | 2019-10-16 | 표준 |
| 2 | IEC 60601-2-66:2019 RLV | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems | 2019-10-16 | 표준 |
| 3 | IEC 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems | 2015-06-26 | 구판 |
| 4 | IEC 60601-2-66:2012 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems | 2012-10-02 | 구판 |
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IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment 상세보기
IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment 상세보기
IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems 상세보기
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