Recognized standard
2900-2-1 First Edition 2017
FDA recognition 13-104 · UL · Software/Informatics
Key facts
| Recognition number | 13-104 |
|---|---|
| Designation | 2900-2-1 First Edition 2017 |
| Title | Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
| Standards developer | Underwriters Laboratories, Inc. |
| Specialty area | Software/Informatics |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | 1.1 This security evaluation standard applies to the testing of network connected 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: