Recognized standard
12417-1 Second edition 2024-02
FDA recognition 3-193 · ISO · Cardiovascular
Key facts
| Recognition number | 3-193 |
|---|---|
| Designation | 12417-1 Second edition 2024-02 |
| 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 | Dec 23, 2024 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the… |
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: