BS EN 80001-1:2011 PDF

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.