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ISO 18193:2021

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation

General information
Valid from 13.08.2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
13.08.2021
Main
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.
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