Recognized standard
EC57:2012
FDA recognition 3-118 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-118 |
|---|---|
| Designation | EC57:2012 |
| Title | Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This recommended practice establishes a method for testing and reporting the performance of algorithms used to detect cardiac rhythm disturbances, including the ST segment. |
At a glance
- 1–9 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: