Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare Systems

Designation Number:
ANSI/CAN/UL 2900-2-1
Standard Type:
National Standard of Canada - Domestic
Standard Sub-Type
Joint Canada-U.S. National Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
35.030
35.110
35.240.50
35.240.80
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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.

Project need:

Proposals to clarify and update ANSI/CAN/UL 2900-2-1

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.