Recognized standard
11073-10103 Second edition 2023
FDA recognition 13-146 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-146 |
|---|---|
| Designation | 11073-10103 Second edition 2023 |
| Title | Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | May 26, 2025 |
| Device classes | Class 3 |
| Scope (excerpt) | The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable… |
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: