UL Standard for Safety for Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems

1 Scope

1.1 This security evaluation standard applies to the testing of network connectable components of healthcare systems.  It applies to, but is not limited to, the following key components:

a) Medical devices;

b) Accessories to medical devices;

c) Medical device data systems;

d) In vitro diagnostic devices;

e) Health information technology;

f) Wellness devices; and

g) All software components used for the secure operation of the device, wherever they may reside, including remote assets.

Note – Combinations of the technologies listed here may be applied to such solutions as “telemedicine,” where a single solution may contain both regulated and unregulated components.