Recognized standard
TIR 41:2011/(R)2017
FDA recognition 3-110 · AAMI · Cardiovascular
Key facts
| Recognition number | 3-110 |
|---|---|
| Designation | TIR 41:2011/(R)2017 |
| Title | Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Cardiovascular |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3 |
| Scope (excerpt) | This Technical Information Report provides guidance for the color coding and marking of IS-1, DF-1, IS4, and DF4connectors to reduce the potential for lead-to-pulse generator connection errors during implant surgery. |
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: