Recognized standard
11073-10407 Second edition 2022-12
FDA recognition 13-135 · ISO · Software/Informatics
Key facts
| Recognition number | 13-135 |
|---|---|
| Designation | 11073-10407 Second edition 2022-12 |
| Title | Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601-2019 and describes a specific, interoperable communication approach for blood pressure monitors. These standards align with… |
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: