Technical evaluation of temperature control equipment for extracorporeal membrane oxygenation
10.3969/j.issn.1005-202X.2025.05.014
- VernacularTitle:体外膜肺氧合温度控制设备技术评价
- Author:
Liping HE
1
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京 100076
- Publication Type:Journal Article
- Keywords:
extracorporeal membrane oxygenation;
temperature control;
effectiveness;
safety
- From:
Chinese Journal of Medical Physics
2025;42(5):648-650
- CountryChina
- Language:Chinese
-
Abstract:
The study introduces the technical characteristics(product type,usage mode,temperature control mode,use environment,etc.)of temperature control equipment for extracorporeal membrane oxygenation,and evaluates effectiveness and safety of the product based on its technical characteristics.Main contributions of the study are as follows:(1)clarifying key technical indicators for effectiveness and safety,as well as common risk sources;(2)putting forward the requirements for the researches on product performance,cleaning and disinfection,and stability.
