Recognized standard
EC53:2013/(R)2020
FDA recognition 3-129 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-129 |
|---|---|
| Designation | EC53:2013/(R)2020 |
| Title | ECG trunk cables and patient leadwires |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface between the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES… |
At a glance
- 10–99 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: