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Standard  I  harmonized

EN 60601-2-41 : 2009 Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009)

CONTENT

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제2-41부: 수술용 및 진단용 조명기구의 기본 안전 및 필수 성능에 관한 개별 요구사항
이 개별 규격은 2.101~2.105까지 정의된 수술용 등기구(SURGICAL LUMINAIRES) 및 진단용 등기구(LUMINAIRES FOR DIAGNOSIS)에 적용되는 요구 사항에 대하여 다룬다. 이하 이들을 기기라고 표기한다.

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=72059186941146784

STANDARD LINK (IEC, ISO, ASTM, ETC.)

HARMONIZED STANDARD LINK

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

RELATED LINK

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