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ISO 18193:2021

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation

Standard Details

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
Standard Type: Main
Document No: ISO 18193:2021
Document Year: 2021
Pages: 33
Edition: 1
  • Section Volume:
  • ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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ISO 18193:2021
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