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Experience gained in applying IEC 80001-1 principles to a medical IT network supporting a clinical information system.

Hegarty, Francis, MacMahon, Silvana Togneri orcid logoORCID: 0000-0003-0179-2436 and Byrne, Patricia (2013) Experience gained in applying IEC 80001-1 principles to a medical IT network supporting a clinical information system. In: The International Conference on Medical Physics (ICMP 2013), 1st -4th Sept 2013, Brighton, UK.

Abstract
IEC 80001-1:2010 [1] recognises that medical devices are incorporated into IT-networks to achieve desirable benefits1. The standard defines the roles, responsibilities and activities that are necessary for the risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security. It applies throughout the life cycle of IT-networks incorporating medical devices and applies to responsible organizations, medical device manufacturers and providers of other information technology. IEC 80001-1:2010 draws on processes set out in ISO 14971:2007 [2] intended to be used by equipment manufacturers to identify hazards associated with medical devices. It also draws on ISO/IEC 20000-1:2011 [3] which specifies the requirements for an IT service provider to meet when implementing an IT service management system
Metadata
Item Type:Conference or Workshop Item (Invited Talk)
Event Type:Other
Refereed:Yes
Subjects:Computer Science > Information technology
Medical Sciences > Health
DCU Faculties and Centres:DCU Faculties and Schools > Faculty of Engineering and Computing > School of Computing
Research Initiatives and Centres > Lero: The Irish Software Engineering Research Centre
Official URL:https://core.ac.uk/download/pdf/35316602.pdf
Funders:Lero Science Foundation Ireland Research Centre for Software
ID Code:28416
Deposited On:22 Jun 2023 13:35 by Silvana Macmahon . Last Modified 22 Jun 2023 13:35
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