Recognized standard
11073-10102 First edition 2014-03-01
FDA recognition 13-75 · ISO · Software/Informatics
Key facts
| Recognition number | 13-75 |
|---|---|
| Designation | 11073-10102 First edition 2014-03-01 |
| Title | Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO/IEEE 11073-10102:2014 extends the IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g. ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by… |
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: