6.2 Cybersecurity

Hospital IT security

To prevent both physical and logical unauthorized access to the device, the organization incorporating the MDSC-8358 MNA in their IT network shall have the necessary state-of-the-art policies, processes, standards and other security measures in place to incorporate, support and protect the device into the IT network. This shall include the application of risk management (e.g. by following IEC 80001-1:2010 or equivalent standards).