Recognized standard
11073-20601 Third Edition 2022-12
FDA recognition 13-136 · ISO · Software/Informatics
Key facts
| Recognition number | 13-136 |
|---|---|
| Designation | 11073-20601 Third Edition 2022-12 |
| Title | Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | ISO and IEEE 11073 standards enable communication between medical devices and external computer systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and optimized communication approach for personal health devices, which may or may not be regulated… |
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: