北京生物醫(yī)學工程

變壓吸附制氧設備部分理化性能檢測方法的研究

Test methods for physicochemical properties of PSA oxygen generator

作者：孫雪黃元禮馮曉明

單位：                      中國食品藥品檢定研究院(北京100050)        

關鍵詞：變壓吸附制氧設備；富氧空氣；理化性能

分類號：

出版年·卷·期（頁碼）：2014·33·4（365-368）

摘要：

目的變壓吸附（pressure swing adsorption, PSA）設備制備的富氧空氣主要用于臨床治療，必須通過質(zhì)量控制以保證患者安全，但目前行業(yè)標準“YY 0298—1998”中對PSA制氧設備制備的氧氣的部分理化指標的檢測方法描述并不清楚。本文針對PSA設備制備的富氧空氣的理化指標中，CO含量、CO2含量、固體物質(zhì)含量和固體物質(zhì)粒徑4個項目的檢測方法做了適當調(diào)整并進行驗證。方法通過優(yōu)化氣路解決了現(xiàn)行標準中無法同時檢測CO和CO2的問題，提高了檢測效率。采用注射器濾頭替代粉塵捕集器進行固體物質(zhì)含量的檢測，并結合倒置顯微鏡對其粒徑進行了考察。結果 CO最小檢出限為0.1×10-6（體積分數(shù)），CO2最小檢出限為0.08×10-6（體積分數(shù)），能夠滿足標準中對CO和CO2含量檢測的規(guī)定，符合方法學驗證的要求。樣品中固體物質(zhì)含量為小于0.1mg/m3、最大固體物質(zhì)粒徑為4.00μm，均符合YY 0298—1998中的要求。結論本文在現(xiàn)行標準的基礎上優(yōu)化試驗方案并對PSA設備制備的富氧空氣進行檢測，得到了較為滿意的結果，對評價PSA設備質(zhì)量具有重要的實際意義。

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 0.1mg/m3. The maximum particle diameter was 4.00μm. 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 important practical significance for the evaluation of PSA oxygen generator.

參考文獻：

［1］Eiji Hirooka. Process for producing oxygen enriched product stream: US, 5 122 164［P］.1992.
［2］Hay. L, Vigor. X. Absorber and Process for the separation by adsorption: US 5 176 721［P］.1993 .
［3］Eteve S, Hay L, Rottner T, et al. Method for producing oxygen by adsorption separation from air: US 5 223 004［P］.1993.
［4］柴玉蓮．我區(qū)醫(yī)用分子篩制氧機結果分析與評價［J］．西藏科技，2011, （8）：40-41．
Chai Yulian. Analysis and evaluation of medical molecular sieve oxygen generator of our area［J］ . Tibet’s Science & Technology，2011, （8）：40-41．
［5］張懷軍，張麗輝，王連玉，等．不同海拔高度對醫(yī)用PSA制氧機特性影響的試驗研究［J］．醫(yī)療衛(wèi)生設備，2011，32（10）：19-23．
Zhang Huaijun, Zhang Lihui, Wang Lianyu, et al. Research on influence of different altitudes to performance of PSA system oxygen machine［J］. Chinese Medical Equipment Journal, 2011，32（10）：19-23．
［6］中華人民共和國國家質(zhì)量監(jiān)督檢驗檢疫總局.GB 8982—2009 醫(yī)用及航空呼吸用氧［S］.北京：中國標準出版社， 2009.
［7］中華人民共和國國家質(zhì)量監(jiān)督檢驗檢疫總局.GB/T 8984.2—1997氣體中一氧化碳、二氧化碳和碳氫化合物的測定第2部分氣體中一氧化碳、二氧化碳和碳氫化合物總含量的測定氣相色譜法［S］.北京：中國標準出版社， 1997.
［8］國家藥典委員會.中華人民共和國藥典（2010年版）二部［M］.北京：化學工業(yè)出版社， 2010.
［9］國家醫(yī)藥管理局.YY 0298-1998 醫(yī)用分子篩制氧設備通用技術規(guī)范［S］.北京：中國標準出版社， 1998.

服務與反饋：

【文章下載】【加入收藏】

提示：您還未登錄，請登錄！點此登錄

51黑料吃瓜在线观看,51黑料官网|51黑料捷克街头搭讪_51黑料入口最新视频