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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 3-54
Standard
ISO ANSI AAMI 7198:2016 Second edition
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
Scope/Abstract
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 included in an informative annex to this
International Standard. This International Standard 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
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.

Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses, Document 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 Organizations
ISO International Organization for Standardization https://www.iso.org/
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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