IT-network

In IEC 82304-1 the responsible organization decides where the IT-network starts and ends, based on where the health software sits. The manufacturer has to tell it what the software needs from that network to stay safe and secure.

a system or systems composed of communicating nodes and transmission links to provide physically linked or wireless transmission between two or more specified communication nodes Note 1 to entry: The scope of the IT-NETWORK in this document is defined by the RESPONSIBLE ORGANIZATION based on where the HEALTH SOFTWARE in the IT-NETWORK is located and the defined use of the IT-NETWORK. It can contain IT infrastructure, home health, or general computing components or systems not intended by design to be used in a healthcare setting. See also 7.2.3.2. [SOURCE: IEC 61907:2009, 3.1.1, modified – The definition has been rephrased and Note 1 to entry has been added.]

IEC 82304-1:2016, clause 3.9