Recognized standard
11318:2002
FDA recognition 3-63 · ISO · Cardiovascular
Key facts
| Recognition number | 3-63 |
|---|---|
| Designation | 11318:2002 |
| Title | Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements. |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 3 |
| Scope (excerpt) | This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: