Abstract：Medical oxygen is an important treatment for respiratory diseases such as severe novel coronavirus patients. Molecular
sieve pressure swing adsorption oxygen production method is simple and convenient, low cost, less energy consumption, easy to
control and so on, has become an important preparation method of clinical oxygen. However, in the clinical use of some molecular
sieve equipment, oxygen concentration is too low, the content of impurities is too high, and the output flow is unstable, which brings
great risks to the clinical application. Based on the basic requirements of product safety and effectiveness, this paper aims to elaborate
and analyze the main concerns in product quality control, such as oxygen concentration, oxygen cleanliness, moisture content, oxygen
flow stability, performance at high altitude, and safety requirements to provide reference for the design and production, registration
and approval, daily supervision of the product.
李国勇，肖杰，任希力，杨阳，马素华，夏文龙. 医用分子筛制氧设备质量控制要点
及对策分析[J]. 中国医疗设备, 2023, 38(10): 14-19.
LI Guoyong, XIAO Jie, REN Xili, YANG Yang, MA Suhua, XIA Wenlong. Quality Control Key Points and Countermeasures of Medical
Molecular Sieve Oxygen Generators. China Medical Devices, 2023, 38(10): 14-19.
