PD IEC/TR 80001-2-2:2012 - Application of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls

PD IEC/TR 80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls

Status : Current   Published : October 2012

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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.




Standard NumberPD IEC/TR 80001-2-2:2012
TitleApplication of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls
StatusCurrent
Publication Date31 October 2012
Normative References(Required to achieve compliance to this standard)IEC 80001-1:2010
Informative References(Provided for Information)ISO 27799:2008, ISO/IEC 27002, ISO 14971:2007, IEC 80001-2-1, ISO 13485:2003, ISO/IEC 27005:2011, IEEE 610.12:1990, ISO/TS 13606-4:2009, ISO/IEC 20000-2:2012, ISO/TR 27809:2007, ISO/IEC 27002:2005, IEC 61907:2009, IEC 62304:2006, IEC 60601-1-6:2006, IEC 60601-1-8:2006, ISO/TS 25238:2007, IEC 80001-2-3, ISO/IEC 15408, ISO/IEC 20000-1:2011, IEC 60300-3-9:1995, ISO/IEC 27001:2005
International RelationshipsIEC/TR 80001-2-2:2012
DescriptorsInformation exchange, Technical documents, Health services, Computer networks, Communication networks, Data processing, Risk analysis, Data security, Data transfer, Project management, Management, Risk assessment, Medical equipment, Personnel
ICS11.040.01
Title in GermanAnwendung des Risikomanagements für IT-Netzwerke, die Medizinprodukte beinhalten. Leitfaden zur Angabe von Bedingungen für die Kommunikationssicherheit von Medizinprodukten, Risiken und Risikobeherrschung
CommitteeCH/62/1
ISBN978 0 580 75100 4
PublisherBSI
FormatA4
DeliveryYes
Pages58
File Size1.487 MB
Price£254.00


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