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Certification & Approval

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Standard  I  harmonized

EN 60601-2-1 : 1998 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998) EN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002)

CONTENT

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)
EN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제2-1부: 1 MeV에서 50 MeV 범위의 전자 가속기의 기본 안전 및 필수 성능에 관한 개별 요구사항
이 국제 표준은 1MeV ~ 50MeV의 범위에서 환자 치료에 사용되는 전자 가속기(이후로는 ME 기기라고 한다)의 기본 안전 및 필수 성능에 적용된다.

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=72059187032048651

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