ISO 18193:2021

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
Edition
: 1

Number of pages
: 33
Technical Committee
: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
ICS
:
11.040.40 Implants for surgery, prosthetics and orthotics

Buy this standard

	Format	Language
std 1 145	PDF + ePub
std 2 145	Paper

CHF145

Life cycle

Now

Published

ISO 18193:2021
Stage: 60.60

Got a question?

Check out our FAQs

Customer care

+41 22 749 08 88

customerservice@iso.org

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