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

MacMahon, Silvana Togneri and Hegarty, Francis J and Byrne, Patricia (2013) Experience gained in applying IEC 80001-1 principles to a medical IT network supporting a clinical information system. Medical Physics International, 1 (2). p. 299. ISSN 2306-4609

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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.

Item Type:	Article
Uncontrolled Keywords:	Medical devices; IEC 80001-1; Medical IT network.
Subjects:	Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Sean McGreal
Date Deposited:	14 Oct 2015 08:42
Last Modified:	14 Oct 2015 08:42
URI:	https://eprints.dkit.ie/id/eprint/490

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