Recognized standard
Std 11073-40101-2020
FDA recognition 13-117 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-117 |
|---|---|
| Designation | Std 11073-40101-2020 |
| Title | Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment. |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The… |
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: