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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
 Rohini Retarekar
  CDRH/OPEQ/OHTII
  240-402-3750
  rohini.retarekar@fda.hhs.gov
 Julie Mackel
  CDRH/OPEQ/OHTII/DHTIIC
  301-796-2879
  Julie.Mackel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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