Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirablebenefits (for example, INTEROPERABILITY), this international standard defines the roles,responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKSincorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEMSECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISKlevels.NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971 [4]. Therelationship between ISO 14971 and this standard is described in Annex A.This standard applies after a MEDICAL DEVIC