ISO/NP TS 27161

Radial expansion resistance characterization of flexible surgical heart valve prostheses

Scope

This document describes an in vitro test method for characterizing the expansion resistance of a flexible surgical heart valve prosthesis against an outward radial force and provides examples for how this design limit should be communicated in the product’s Instructions for Use (IFU). This document represents a consensus reached among manufacturers, independent bioengineers, and clinicians, and is underpinned by interlaboratory studies.
This document relates to flexible surgical heart valve prostheses and is intended to be used in conjunction with ISO 5840-1:2021 and ISO 5840-2:2021. In addition to rigid (mechanical) valves, sutureless valves, stentless valves, valved conduits, and size-adjustable valves that are intended to operate across a range of expanded diameters are also not included.