Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

046

Date of Entry 12/23/2016

FR Recognition Number

3-144

Standard

ISO 7198 Second edition 2016-08-01
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

Scope/Abstract

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.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

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

Relevant FDA Guidance and/or Supportive Publications*

Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Issued November 2000.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Julie Mackel

CDRH/OPEQ/OHTII/DHTIIC/

301-796-2879

Julie.Mackel@fda.hhs.gov

Nathan Weidenhamer

CDRH/OPEQ/OHTII/DHTIIB/

240-402-3577

Nathan.Weidenhamer@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization