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Standard  I  harmonized

EN 80601-2-35 : 2009 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009)

CONTENT

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009)
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

의료용 전기기기 ─ 제2-35부: 의료용 온열 담요, 패드, 매트리스의 기본 안전 및 필수 성능에 관한 개별 요구사항
KS P IEC 60601－1의 1.1에 따르는 외에 다음 사항을 추가한다. 이 개별 기준 규격은 2.2.102, 2.2.106, 2.2.107에 정의된 공기 부양 매트리스와 강제 순환 시스템을 포함하는 담요, 패드, 매트리스에 대한 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=72059187093208679

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