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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
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
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
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FDA recognition of ISO 5840-1 First edition 2015-09-15 [Rec# 3-145] will be superseded by recognition of ISO 5840-1 Second edition 2021-01 [Rec# 3-174].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
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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.