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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.
Transition Period
FDA recognition of ISO 5840-1 First edition 2015-09-15 [Rec# 3-145] will be superseded by recognition of ISO 5840-1 Second edition 2021-01 [Rec# 3-174]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-145] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-145] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3925 Replacement Heart-Valve Class 3 DYE
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
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.
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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