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APPLICABLE STANDARDS

Harmonized, EN, IEC, ISO and so on

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Standard  I  harmonized
EN 60118-13 : 2005 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CONTENT
Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

보청기 ― 제13부: 전기자기 적합성
KS C IEC 60118의 이 부는 보청기에 대한 모든 EMC 현상을 포함한다. 이 규격은 측정 방법과 IEC 61000-4-3에서 정의하고 있는 디지털 수화기 시스템에서 발생하는 고주파 전기 자기장에 대한 보청기 내성에
CONDITIONS
    invasive device
    non-invasive device

    active device


    only software (active device)
    non-active device
    unintended medical purpose

    wireless


    including software
    single-use
    sterilization
    radiation
    hazardous substances
KS STANDARD LINK
https://standard.go.kr/streamdocs/view/sd;streamdocsId=72059187030771471
STANDARD LINK (IEC, ISO, ASTM, ETC.)
HARMONIZED STANDARD LINK
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
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