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Certification & Approval

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Standard  I  

EN 60601-1-3 : 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)

CONTENT

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)
EN 60601-1-3:2008/AC:2010
EN 60601-1-3:2008/A11:2016
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항 ─ 보조표준: 진단용 X선 장치의 방사선 방어
이 규격은 진단용 X선 장치 및 그러한 장치의 부분 조립품의 안전에 관한 요구 사항에 대하여 규정한다.

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=72059186254679730

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

ATTACHED FILE