ISO 18193:2021
p
ISO 18193:2021
80232

Abstract

 Preview

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 

  •  :  Published
     : 2021-08
  •  : 1
     : 33
  •  : ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

Buy this standard

en
Format Language
std 1 138 PDF + ePub
std 2 138 Paper
  • CHF138

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.