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ISO 18193:2021

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation

Aug 13, 2021

General information

60.60     Aug 13, 2021

ISO

ISO/TC 150/SC 2

International Standard

11.040.40  

English  

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Scope

This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to:
—    introducers (e.g., guidewires) as addressed in ISO 11070,
—    isolated organ perfusion cannulae, and
—    intravascular catheters as addressed in ISO 10555-3.

Life cycle

NOW

PUBLISHED
ISO 18193:2021
60.60 Standard published
Aug 13, 2021

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
ISO 18193:2021/PRF Amd 1