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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 3-145
Standard
ISO 5840-1 First edition 2015-09-15
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
U.S. Identical Adoption
ANSI AAMI ISO 5840-1:2015
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
Scope/Abstract
ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.

ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate of the heart valve substitute to be implanted.

ISO 5840-1:2015 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Aortic Valve, Prosthesis, Percutaneously Delivered Class 3 NPT
Unclassified Heart-Valve, Mechanical Class 3 LWQ
Unclassified Heart-Valve, Non-Allograft Tissue Class 3 LWR
Unclassified Prosthesis, Mitral Valve, Percutaneously Delivered Class 3 NPU
Unclassified Pulmonary Valve Prosthesis Percutaneously Delivered Class f NPV
§870.3925 Replacement Heart-Valve Class 3 DYE
FDA Technical Contact
 Changfu Wu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-6086
  changfu.wu@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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