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.