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; and

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.

Summary of Topics

This revision for UL 2900-2-1 dated November 6, 2020 is being issued to clarify and update UL 2900-2-1 and add an informational Annex to provide rationale for the requirements in UL 2900-2-1; 1.1, 2.4, 2.5, Section 2A, 4.1, 5.1, 7.1, 8.1, 9.1, 10.1, 11.1, 12.1.2, 12.4.3.1, 12.4.3.16, 12.4.3.17, 13.3, 15.1, 16.1, 18.1, 20.3.5, Annex A