变压吸附制氧设备部分理化性能检测方法的研究

Test methods for physicochemical properties of PSA oxygen generator

目的变压吸附(pressure swing adsorption,PSA)设备制备的富氧空气主要用于临床治疗,必须通过质量控制以保证患者安全,但目前行业标准"YY 0298—1998"中对PSA制氧设备制备的氧气的部分理化指标的检测方法描述并不清楚。本文针对PSA设备制备的富氧空气的理化指标中,CO含量、CO,含量、固体物质含量和固体物质粒径4个项目的检测方法做了适当调整并进行验证。方法通过优化气路解决了现行标准中无法同时检测CO和CO_2的问题,提高了检测效率。采用注射器滤头替代粉尘捕集器进行固体物质含量的检测,并结合倒置显微镜对其粒径进行了考察。结果 CO最小检出限为0.1×10^(-6)(体积分数),CO_2最小检出限为0.08×10^(-6)(体积分数),能够满足标准中对CO和CO_2含量检测的规定,符合方法学验证的要求。样品中固体物质含量为小于0.1 mg/m^3、最大固体物质粒径为4.00μm,均符合YY 0298—1998中的要求。结论本文在现行标准的基础上优化试验方案并对PSA设备制备的富氧空气进行检测,得到了较为满意的结果,对评价PSA设备质量具有重要的实际意义。

Objective Oxygen-enriched air generated by pressure swing adsorption （PSA） equipment is usually used for clinical treatment and the quality control is highly required to ensure the patients＇ safety. Parts of the test method description in the current industry standard （ YY 0298 - 1998） of PSA oxygen generator＇ s physicochemical properties are not feasible. This study adjusts and validates the test methods of the content of carbon monoxide, the content of carbon dioxide, the content of solid substances and the particle diameter of solid substance in the physicochemical properties of oxygen-enriched air. Methods The content of CO and CO2 could be detected simultaneously by optimization of gas path and detection efficiency was improved. The syringe filter was used in the test for solid content instead of particle collector, and the inverted microscope was used in the test of particle size. Results The minimum detection limits of CO and CO2 were 0. 1× 10^-6 （ volume fraction） and 0.08 ×10^-6（ volume fraction）, respectively. The methodology validation was carried out and conformed to the provisions. The content of solid substances was less than 0. 1 mg/m^3. The maximum particle diameter was 4.00 μm. Conclusions PSA oxygen generator was tested by optimizing the test methods based on the current standard. These methods were accurate and reliable and it had impcrtant practical significance for the evaluation of PSA oxygen generator.