ISO 18193:2021

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation
Autor: ISO
Código ICS: 11.040.40
Vigente
$118.000

Alcance

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.

Especificaciones de la Norma
Fecha de Publicación 13/08/2021
Título Secundario Implants cardiovasculaires et organes artificiels — Canules pour circulation extracorporelle
Páginas Técnicas 33
Idioma Inglés