CNCA 08C-040-2001
Implementation Rules for Compulsory Certification of Medical Devices Artificial Heart-Lung Machine Bubble Oxygenator (English Version)

Standard No.

CNCA 08C-040-2001

Language

Chinese, Available in English version

Release Date

2001

Published By

CN-CNCA

Scope

This rule applies to artificial heart-lung machine bubbling oxygenators. This product is a medical device used to replace human lung function for gas exchange when performing open-heart surgery with extracorporeal circulation.