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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 3-133
Standard
ISO 5840-3 First edition 2013-03-01
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
U.S. Identical Adoption
ANSI AAMI ISO 5840-3:2013
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
Scope/Abstract
ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 7.2.4.2 Device structural component fatigue assessment.
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.

Section 7.2.4.2 conflicts with section In Vitro Testing in reference listed below.
Transition Period
FDA recognition of ISO 5840-3 First edition 2013-03-01 [Rec# 3-133] will be superseded by recognition of ISO 5840-3 Second edition 2021-01 [Rec# 3-173]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-133] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-133] will not be accepted.
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 Prosthesis, Mitral Valve, Percutaneously Delivered Class 3 NPU
Unclassified Pulmonary Valve Prosthesis Percutaneously Delivered Class f NPV
Relevant FDA Guidance and/or Supportive Publications*
Fernando A, Hillebrenner M, Stewart S, Swain J, Hampshire V, Zuckerman B (2011). U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery. Cardiovascular Engineering and Technology, 2(2): 62-5.
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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