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Standard  I  harmonized

EN 60601-2-27 : 2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)

CONTENT

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)
EN 60601-2-27:2006/AC:2006
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제2-27부: 심전도 감시기기의 기본 안전 및 필수 성능에 관한 개별 요구사항
이 규격은 2.101에 정의된 것과 같이 심전도 감시기[ECG(ELECTROCARDIOGRAPHIC) MONITOR－ING EQUIPMENT]의 안전에 관한 개별 규격을 다루며, 이후에 기기(EQUIPMENT)라고 호칭할 때에는 심전도 감시기를 가리키는 것으로 한다.

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=72059186996516862

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