| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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3-205
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| Standard | |
ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025]
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)] |
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Scope/AbstractThis 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 size 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.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 7.2.5.3 Device structural component fatigue assessment
Annex J.3.1 General
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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. |
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Transition Period
| FDA recognition of ISO 5840-1 Second edition 2021-01 [Rec# 3-174] will be superseded by recognition of ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025] [Rec# 3-205]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-174] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 3-174] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.3925 |
Replacement Heart-Valve
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Class 3
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DYE
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| N/A |
Heart-Valve, Mechanical |
Class 3
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LWQ
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| N/A |
Heart-Valve, Non-Allograft Tissue |
Class 3
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LWR
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| N/A |
Aortic Valve, Prosthesis, Percutaneously Delivered |
Class 3
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NPT
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| N/A |
Prosthesis, Mitral Valve, Percutaneously Delivered |
Class 3
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NPU
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| N/A |
Pulmonary Valve Prosthesis Percutaneously Delivered |
HDE
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NPV
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
