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Anwendung des Risikomanagements für IT-Netzwerke, die Medizinprodukte beinhalten - Teil 2-2: Leitfaden zur Angabe von Bedingungen für die Kommunikationssicherheit von Medizinprodukten, Risiken und Risikobeherrschung Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Anwendung des Risikomanagements für IT-Netzwerke, die Medizinprodukte beinhalten - Teil 2-2: Leitfaden zur Angabe von Bedingungen für die Kommunikationssicherheit von Medizinprodukten, Risiken und Risikobeherrschung
Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Shortname IEC TR 80001-2-2:2012-07
Dokumentnummer 80001-2-2
Ausgabedatum 2012-07-00
Erwerb bei https://www.vde-verlag.de/iec-normen/218983/iec-tr-80001-2-2-2012.html
Internationales Gremium IEC/TC 62/SC 62A
Thema Medizinprodukte
Sektor Gesundheit, Informationstechnik und Telekommunikation
Branche Medizinische Versorgung

  • Einführungsbeitrag (short) EN:
    IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk.The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.
  • IEC 80001-1 (2010-10)

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    Transnational Transnational

    Branche: Medizinische Versorgung
    Ergebnis 1

    Einzelne Vorschriften

    Art. 3 I lit. a, III lit. e; 9 II; 10 I, V; 40 I; 42 I




    Transnational Transnational

    Branche: Medizinische Versorgung
    Ergebnis 2

    Einzelne Vorschriften

    Alle, inbes. Art. 11; 17 IV f); 19 I, II; 20 I, II; 24 II b), e), f), g), h), j); 26 d); 36 d; 44 I d), e)




    Transnational Transnational

    Branche: Medizinische Versorgung
    Ergebnis 3

    Einzelne Vorschriften

    Alle, insbes. Art. 14-16




    Transnational Transnational

    Branche: Medizinische Versorgung
    Ergebnis 4

    Einzelne Vorschriften

    Art. 5; 24; 25; 28; 29; 32; 33; 34; 35; 36; 37; 38; 39; 40; 42; 43; 45; 46; 47; 49; 51; 57; 58




    Transnational Transnational

    Branche: Medizinische Versorgung
    Ergebnis 5

    Einzelne Vorschriften

    Alle