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ISO 18193:2021

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

Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation

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This document specifies requirements for sterile, single-use cannulae for removal and delivery of patientsâ' 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.

SDO ISO: International Organization for Standardization
Document Number ISO 18193
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 150/SC 2
Publish Date Document Id Type View
Not Available ISO 18193:2021 Revision