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ISO 18242:2016

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps

Aug 15, 2016

General information

90.93     Aug 1, 2023

ISO

ISO/TC 150/SC 2

International Standard

11.040.40  

English  

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Published

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Scope

ISO 18242:2016 specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.
It does not apply to
- centrifugal pumps used as ventricular assist devices, and
- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).

Life cycle

NOW

PUBLISHED
ISO 18242:2016
90.93 Standard confirmed
Aug 1, 2023

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 18242:2016/Amd 1:2023