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Standard  I  harmonized

EN 60601-2-11 : 1997 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)

CONTENT

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제2-11부: 감마선치료기의 기본안전 및 필수성능에 대한 개별 요구사항
본 표준은 감마선 치료기의 개별 표준으로 감마선치료기의 안전성과 필수성능에 대한 개별요구사항을 기술한 표준이다.

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=72059187032875513

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