Application of risk management for IT-networks incorporating medical devices - Roles, responsibilities and activities
Application of risk management for IT-networks incorporating medical devices - Roles, responsibilities and activities
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BS EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), this international standard 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). This international standard does not specify acceptable risk levels.
BS EN 80001-1 is the standard that applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. BS EN 80001-1 does not cover pre-market risk management. It applies throughout the life cycle of IT-networks incorporating medical devices.
This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. It 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.
BS EN 80001-1 does not apply to personal use applications where the patient, operator and responsible organization are one and the same person. It does not address regulatory or legal requirements.
An increasing number of medical devices are designed to exchange information electronically with other equipment in the us...
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