Recognized standard
7198 Second edition 2016-08-01
FDA recognition 3-144 · ISO · Cardiovascular
Key facts
| Recognition number | 3-144 |
|---|---|
| Designation | 7198 Second edition 2016-08-01 |
| Title | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 7198:2016 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 included in an… |
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: