European Medical Device Directive: impact on nuclear medicine

JD Kuyvenhoven, P Lahorte, K Persyn, E De Geest, PW van Loon, F Jacobs, PP van Rijk, [No Value] Lemahieu, R A Dierckx

    OnderzoeksoutputAcademicpeer review

    3 Citaten (Scopus)

    Samenvatting

    The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the risk classification of products, the compliance and evaluation process and the CE-marking regulations. Furthermore, some practical implications are highlighted for devices and tools relevant to the field of nuclear medicine such as radiation detectors, gamma- and PET-cameras and software. (C) 2001 Elsevier Science Ltd. All rights reserved.

    Originele taal-2English
    Pagina's (van-tot)207-212
    Aantal pagina's6
    TijdschriftComputerized medical imaging and graphics
    Volume25
    Nummer van het tijdschrift2
    StatusPublished - 2001
    EvenementSymposium on Frontiers in Nuclear Medicine Technology - , Belgium
    Duur: 6-mei-19997-mei-1999

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