Recognized standard
11073-10472 First edition 2012-11-01
FDA recognition 13-69 · ISO · Software/Informatics
Key facts
| Recognition number | 13-69 |
|---|---|
| Designation | 11073-10472 First edition 2012-11-01 |
| Title | Health informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1 |
| Scope (excerpt) | Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10472:2012 establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines (e.g. cell phones, personal computers, personal health… |
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: