Experience gained in applying IEC 80001-1 principles
to a medical IT network supporting a clinical
information system.
Hegarty, Francis, MacMahon, Silvana TogneriORCID: 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.
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