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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
ANSI AAMI ISO 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
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.
FDA Technical Contact
 Dorothy Abel
  FDA/OMPT/CDRH/ODE/DCD/VSDB/
  301-796-6366
  dorothy.abel@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
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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