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:

1. a) Medical devices;

2. b) Accessories to medical devices;

3. c) Medical device data systems;

4. d) In vitro diagnostic devices;

5. e) Health information technology;

6. f) Wellness devices; and

7. 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.