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目的了解天津市固定式节育器中环氧乙烷残留量,客观评价其含量水平,为加强监管提供理论依据。方法按照《医用输液、输血、注射器具检验方法第1部分:化学分析方法》(GB/T14233.1-2008)的要求对天津市2009～2010年固定式节育器残留量进行抽样和检测,参照《医疗器械生物学评价第7部分:环氧乙烷灭菌残留量》(GB/T16886.7-2001)进行分析和评价。结果 2009～2010年共监测样品108份,合格率为91.67%。2009年、2010年的合格率分别为100%、83.46%。不同季度的环氧乙烷残留量测定,第一季度最高,且与其他3个季度的含量相比差异有统计学意义(χ2=33.4,P﹤0.01)。结论天津市固定式节育器中环氧乙烷残留量整体合格率较高,但各个季度合格率有所不同,应进一步加强监管,提高其卫生消毒质量,保护广大消费者健康。
Objective To understand the residual ethylene oxide content of fixed IUDs in Tianjin and to objectively evaluate the content of ethylene oxide so as to provide a theoretical basis for strengthening supervision. Methods The samples of fixed IUDs in Tianjin from 2009 to 2010 were sampled and tested in accordance with the requirements of “Methods for testing medical transfusion, transfusion and injection apparatus - Part 1: Chemical analysis methods” (GB / T14233.1-2008) “Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues” (GB / T16886.7-2001) for analysis and evaluation. Results A total of 108 samples were monitored from 2009 to 2010 with a pass rate of 91.67%. The passing rates in 2009 and 2010 were 100% and 83.46% respectively. The ethylene oxide content in different quarters was the highest in the first quarter, and the difference was statistically significant compared with the other three quarters (χ2 = 33.4, P <0.01). Conclusion The fixed rate of ethylene oxide residues in fixed IUDs in Tianjin is relatively high. However, the passing rates in all quarters are different. Supervision and control should be further strengthened to improve the hygiene and disinfection quality and protect the health of consumers.