Recognized standard
EC12:2000/(R)2015
FDA recognition 3-52 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-52 |
|---|---|
| Designation | EC12:2000/(R)2015 |
| Title | Disposable ECG electrodes |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring. |
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: