Recognized standard
Std 11073-10419:2023
FDA recognition 13-145 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-145 |
|---|---|
| Designation | Std 11073-10419:2023 |
| Title | Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | May 26, 2025 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that… |
At a glance
- None Product codes
- 10–99 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: