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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 3-147
Standard
ISO 5840-2 First Edition 2015-09-15
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
U.S. Identical Adoption
ANSI AAMI ISO 5840-2:2015
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Scope/Abstract
ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.

ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate of the surgical heart valve substitute to be implanted.

ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical 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 surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical 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 durability assessment.
Clause 7.2.4.3 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.
Transition Period
FDA recognition of ISO 5840-2 First Edition 2015-09-15 [Rec# 3-147] will be superseded by recognition of ISO 5840-2 Second edition 2021-01 [Rec# 3-175]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-147] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-147] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Heart-Valve, Mechanical Class 3 LWQ
Unclassified Heart-Valve, Non-Allograft Tissue Class 3 LWR
§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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