Recognized standard
7198:2016 Second edition
FDA recognition 3-54 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-54 |
|---|---|
| Designation | 7198:2016 Second edition |
| Title | Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is… |
At a glance
- 1–9 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: