scope:

1.1 Purpose 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 the KEY PROPERTIES. This international standard does not specify acceptable RISK levels. 1.2 Field of application This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES. his 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. NOTE 1 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation or assembly of the MEDICAL DEVICE according to the manufacturer's ACCOMPANYING DOCUMENTS is not subject to the provisions of this standard regardless of who installs or assembles the MEDICAL DEVICE. NOTE 2 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to that MEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by the manufacturer, is subject to the provisions of this standard. This standard applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and other providers of information technologies for the purpose of comprehensive RISK MANAGEMENT. This standard does not apply to personal use applications where the PATIENT, OPERATOR and RESPONSIBLE ORGANIZATION are one and the same person. This standard does not address regulatory or legal requirements.