Reference number
ISO 18193:2021
© ISO 2024
International Standard
ISO 18193:2021
Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation
Edition 1
2021-08
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Published (Edition 1, 2021)

ISO 18193:2021

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Format
CHF 151
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2021-08
    Stage
    : International Standard published [60.60]
  • Edition
     : 1
    Number of pages
     : 33
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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