Recognized standard
11073-20101 First edition 2004-12-15
FDA recognition 13-49 · ISO · Software/Informatics
Key facts
| Recognition number | 13-49 |
|---|---|
| Designation | 11073-20101 First edition 2004-12-15 |
| Title | Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are to: - Provide real-time plug-and-play… |
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: