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Standard  I  harmonized

EN 556-2 : 2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

CONTENT

멸균

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

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