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一次性射頻等離子手術(shù)電極滅菌方式的選擇與驗(yàn)證

Selection and validation of electrode sterilization methodsfor radiofrequency plasma surgery

作者: 佟笛  王燕  劉志成 
單位:首都醫(yī)科大學(xué)生物醫(yī)學(xué)工程學(xué)院(北京100069)
關(guān)鍵詞: 一次性射頻等離子手術(shù)電極;滅菌方法;環(huán)氧乙烷滅菌;滅菌環(huán)境;有毒氣體殘留 
分類號(hào):R318.04
出版年·卷·期(頁(yè)碼):2017·36·5(507-512)
摘要:

目的 選擇一次性射頻等離子手術(shù)電極滅菌方式,并對(duì)滅菌效果進(jìn)行驗(yàn)證。方法 綜合比較4種常用滅菌方式的特征和環(huán)境,基于一次性射頻等離子手術(shù)電極材料及特性,選擇環(huán)氧乙烷滅菌法進(jìn)行滅菌。滅菌完成后確認(rèn)一次性射頻等離子手術(shù)電極的性能,并采用生物指示劑對(duì)產(chǎn)品微生物及環(huán)氧乙烷殘留進(jìn)行測(cè)試。結(jié)果 采用環(huán)氧乙烷滅菌方法對(duì)一次性射頻等離子手術(shù)電極進(jìn)行滅菌,滅菌器內(nèi)滅菌參數(shù)為:預(yù)真空度60kPa±5kPa、滅菌溫度50℃±5℃、相對(duì)濕度55%RH±20%RH、滅菌壓力0~5kPa、保壓時(shí)間1min、加藥計(jì)量<895g、滅菌劑作用時(shí)間6h、排殘真空度-60kPa±5kPa、排殘次數(shù)3次、每次排殘時(shí)間為30min、有毒氣體解吸時(shí)間為14d。結(jié)論 環(huán)氧乙烷滅菌法是針對(duì)包裝后一次性射頻等離子手術(shù)電極可行且有效的滅菌方法。

Objective To select the sterilization mode of disposable radiofrequency plasma electrode,and to verify the sterilization effect. Methods We compared the characteristics and environment of the four commonly used sterilization methods,and chose ethylene oxide sterilization method based on the materials and characteristics of disposable radiofrequency plasma surgical electrodes. After sterilization,the performance of the disposable radiofrequency plasma electrode was confirmed,and biological indicators were used to test the products,microorganisms and ethylene oxide residues. Results We used ethylene oxide sterilization method to sterilize the disposable radiofrequency plasma surgical electrode,the sterilization parameters were determined as follows:pre vacuum 60kPa±5kPa,sterilization temperature 50℃±5℃, relative humidity 55%RH + 20%RH,sterilization pressure 0-5kPa,the holding time 1min,the dosing rate <895g,the sterilizing agent time 6h,the residual vacuum degree -60kPa±5kPa,the number of times of residue removal 3 times,the time of each row 30min,the desorption time of toxic gas14d. Conclusion Ethylene oxide sterilization is a feasible and effective sterilization method for disposable radiofrequency plasma electrode after packaging.

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