Recognized standard
Std 11073-10201-2018
FDA recognition 13-111 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-111 |
|---|---|
| Designation | Std 11073-10201-2018 |
| Title | Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient… |
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: