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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 061 Date of Entry 12/18/2023 
FR Recognition Number 3-190
Standard
ISO  PAS 7020 First edition 2023-05
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
Scope/Abstract
This document describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies.

This document relates to surgical heart valve prostheses and is intended to be used in conjunction with ISO 5840-1:2021 and ISO 5840-2:2021. Where noted, the requirements of this document clarify certain requirements of ISO 5840-1 and/or ISO 5840-2. Specific methodologies are included for flexible leaflet (bioprosthetic) and rigid (mechanical) valves. Sutureless valves, stentless valves and valved conduits are not included.
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.
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
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Changfu Wu
  CDRH/OPEQ/OHTII/DHTIIB
  301-796-6086
  Changfu.Wu@fda.hhs.gov
 Kevin Soucy
  CDRH/OPEQ/OHTII/DHTIIB
  240-402-3682
  Kevin.Soucy@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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