| ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 3-144 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
| FDA Tech | Dorothy Abel FDA/OMPT/CDRH/ODE/DCD/VSDB/ 301-796-6366 dorothy.abel@fda.hhs.gov |
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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 informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.3450 | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Class 2 | DSY |
| §870.3450 | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | Class 2 | DYF |
| Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Issued November 2000. |