ISO/PAS 7020:2023

Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2

Publication date: 17 maj 2023

General information

Current stage: 60.60 Effective date: 17 maj 2023

Originator: ISO

Owner: ISO/TC 150/SC 2

Type: Publicly Available Specification

ICS: 11.040.40

Gjuha: anglisht

Buying

Statusi: Publikuar

PDF - 7 123 Lekë

Paper - 7 123 Lekë

CD - 7 123 Lekë

Language

Language in which you want to receive the document.

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
60.60 Standard published
17 maj 2023

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.