DIN EN 80001-1:2011-11

In medical practice, more and more medical devices are incorporated into IT-networks. Interoperability is increasingly required. This 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. This standard applies after the product on the market was placed on the market for the first time if one or more medical device(s) has (have) been purchased by the responsible organization and is (are) intended to be incorporated into IT-networks. 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. The standard is directed at responsible organizations, medical device manufacturers and providers of other information technology. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person. The interpretation of the requirements, in particular of clauses 3.5 (also 3.6) and 4.3.4 can vary, depending on whether it is formulated from the point of view of the responsible organization or manufacturer. In this connection, an essential question is the agreement on duty to deliver and duty to collect for the provision and definition of "important updated information". The DKE invites all interested experts to revise the content within the framework of an International Technical Report "Guidance for Responsibility Agreement(s) and Information Provision among Medical Device Manufacturer, IT Provider and Responsible Organizations" and to publish it as IEC 8000-2-x. This standard does not address regulatory or legal requirements. The responsible subcommittee is UK 811.3 "Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung" ("Safety of medical devices/systems/facilities for network applications") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN.