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ISO 18193:2021

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation ISO 18193:2021

Publication date:   Aug 13, 2021

General information

90.20   Standard under periodical review   Jul 15, 2026

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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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
90.20 Standard under periodical review
Jul 15, 2026

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 18193:2021/Amd 1:2025




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