Recognized standard
14117 Second edition 2019-09
FDA recognition 3-161 · ISO · Cardiovascular
Key facts
| Recognition number | 3-161 |
|---|---|
| Designation | 14117 Second edition 2019-09 |
| Title | Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems. NOTE This… |
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: