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Certification & Approval

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Standard  I  harmonized

EN 13795-2 : 2019 Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

CONTENT

외과 용 의류 및 커튼-요구 사항 및 테스트 방법-2 부 : 클린 에어 슈트

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