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

ISO/PAS-7020 - 1ST EDITION - CURRENT


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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.

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11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ISO/PAS 7020:2023

Revision Level

1ST EDITION

Status

Current

Publication Date

May 1, 2023

Committee Number

ISO/TC 150/SC 2