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Certification & Approval

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Standard  I  harmonized

EN 14079 : 2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

CONTENT

비능동성 의료 기기-흡수성면 거즈 및 흡수성 면화 및 비스코스 거즈에 대한 성능 요구 사항 및 테스트 방법

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

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