Recognized standard

Std 11073-10206-2022

FDA recognition 13-139 · IEEE · Software/Informatics

Key facts

Recognition number 13-139
Designation Std 11073-10206-2022
Title Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
Standards developer Institute of Electrical and Electronic Engineers
Specialty area Software/Informatics
Date of entry May 29, 2024
Scope (excerpt) Within the context of the ISO/IEEE 11073 family of standards for device communication, a simplified framework for making an abstract model of personal health data is available in this standard. The specification addresses the structure and content of information. It does not address communication of…

At a glance

  • None Product codes
  • 10–99 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:

Browse all FDA-recognized consensus standards