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ISO/PAS 7020:2023

Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 ISO/PAS 7020:2023

Publication date:   May 17, 2023

General information

90.92   Standard to be revised   Sep 29, 2025

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

Publicly Available Specification

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO/PAS 7020:2023
90.92 Standard to be revised
Sep 29, 2025

REVISED BY

IN_DEVELOPMENT
ISO/CD TS 7020




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