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Certification & Approval

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Standard  I  harmonized

EN 1060-3:1997+A2 : 2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

CONTENT

혈압계

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

RELATED LINK

•   https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020D0437 1917회 연결

ATTACHED FILE