Recognized standard
12417-1 First edition 2015-10-01
FDA recognition 3-143 · ISO · Cardiovascular
Key facts
| Recognition number | 3-143 |
|---|---|
| Designation | 12417-1 First edition 2015-10-01 |
| Title | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 3 |
| Scope (excerpt) | ISO 12417-1:2015 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part… |
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: