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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 057 Date of Entry 12/20/2021 
FR Recognition Number 3-174
Standard
ISO  5840-1 Second edition 2021-01
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
Scope/Abstract
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate of the heart valve substitute to be implanted.

ISO 5840-1 outlines an approach for verifying/validating 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 can 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:
-7.2.5.3 Device structural component fatigue assessment
-Annex J.3.1 General
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.

This standard is recognized in part because:
-Section 7.2.5.3 is in conflict with published literature, see section on "In Vitro Testing" in the reference listed below.
-Annex J.3.1 is in conflict with published literature, see section on "In Vitro Testing" in the reference listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3925 Replacement Heart-Valve Class 3 DYE
N/A Heart-Valve, Mechanical Class 3 LWQ
N/A Heart-Valve, Non-Allograft Tissue Class 3 LWR
N/A Aortic Valve, Prosthesis, Percutaneously Delivered Class 3 NPT
N/A Prosthesis, Mitral Valve, Percutaneously Delivered Class 3 NPU
N/A Pulmonary Valve Prosthesis Percutaneously Delivered HDE NPV
Relevant FDA Guidance and/or Supportive Publications*
Fernando A, Hillebrenner M, Stewart S, Swain J, Hampshire V, Zuckerman B. U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery. Cardiovasc Eng Technol 2011; 2(2): 62-5.

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 Contact
 Changfu Wu
  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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