Recognized standard
11073-10419 First edition 2016-06-15
FDA recognition 13-91 · ISO · Software/Informatics
Key facts
| Recognition number | 13-91 |
|---|---|
| Designation | 11073-10419 First edition 2016-06-15 |
| Title | Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done… |
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: