Recognized standard
PC76:2021
FDA recognition 3-185 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-185 |
|---|---|
| Designation | PC76:2021 |
| Title | Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | May 29, 2023 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | Provides requirements and test protocols for implantable pacemakers and ICDs exposed to magnetic resonance imaging. Physicians are increasingly using magnetic resonance imaging as tool for differential diagnostic, thus exposing pacemakers and ICD patients to such equipment. Current product standards… |
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: