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EN 60601-2-33 : 2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)

CONTENT

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
EN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013)
EN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015)
EN 60601-2-33:2010/AC:2016-03
EN 60601-2-33:2010/A12:2016

의료용 전기기기 ─ 제2-33부: 진단용 자기공명기기의 기본 안전 및 필수 성능에 관한 개별 요구사항
다음 사항을 제외하고는 KS P IEC 60601－1의 1.에 따른다.1.1 적용 범위추 가이 개별 기준 규격은 2.2.101에 정의된 자기 공명 전산화 단층 촬영 장치에 적용된다.이 개별 기준 규격은 연구 목적의 자기 공명 전산화 단층 촬영 장치에는 적용되지 않는다.

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=72059187084436216

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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