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BSI BS EN 80001-1:2011

Application of risk management for IT-networks incorporating medical devices -- Roles, responsibilities and activities
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BSI BS EN 80001-1:2011

Application of risk management for IT-networks incorporating medical devices -- Roles, responsibilities and activities

PUBLISH DATE 2011
PAGES 46
BSI BS EN 80001-1:2011
IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.
SDO BSI: British Standards Institution
Document Number EN 80001-1
Publication Date April 30, 2011
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/62/1
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