Recognized standard
Std 11073-10422-2016
FDA recognition 13-93 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-93 |
|---|---|
| Designation | Std 11073-10422-2016 |
| Title | Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | Within the context of the ISO/IEEE 11073(TM) family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth urine analyzer devices and managers (e.g., cell phones, personal computers, personal health appliances, set-top… |
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: