scope:

1.1 Purpose This Technical Report helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to establish a RISK MANAGEMENT framework, before the organization embarks on a detailed RISK ASSESSMENT of an individual instance of a MEDICAL IT-NETWORK. The steps are supported by a series of decision points to steer the RESPONSIBLE ORGANIZATION through the PROCESS of understanding the MEDICAL IT-NETWORK context and identifying any organizational changes required to execute the responsibilities of TOP MANAGEMENT as defined Figure 1 of IEC 80001-1:2010.