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APPLICABLE STANDARDS

Harmonized, EN, IEC, ISO and so on

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Standard  I  harmonized
EN 60627 : 2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
CONTENT
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
EN 60627:2001/AC:2002
Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

진단용 엑스선 영상장치 ─ 범용 및 유방 촬영용 산란선 제거 그리드의 특성
이 규격은 특히 환자 몸 안에서 발생하는 산란 방사선(SCATTERED RADIATION)의 입사를 감소시켜 X선 패턴(X-RAY PATTERN)의 콘트라스트를 높일 목적으로 진단용 X선 영상 장치의 수상면(IMAGE RECEPTION AREA) 앞에 놓고 사용하는 산란선 제거 그리드(ANTI-SCATTER GRIDS)의 특성을 정의, 결정, 표시하는 데 적용한다.
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=72059187082265308
STANDARD LINK (IEC, ISO, ASTM, ETC.)
HARMONIZED STANDARD LINK
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
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