高流量湿化氧疗装备的有效使用期限评价方法研究

Study on the Effective Service Term Evaluation Method of HFNC Equipment

目的验证高流量湿化氧疗装备的有效使用期限,保证使用者的安全和有效。方法按二项分布原则,抽样数量为10台,每天实际有效试验时间为22 h,共进行了30 d试验。在寿命试验的基础上,运用加速寿命模型,通过事件压缩和应力加速相结合的方式进行加速,评价正常工作应力下的可靠性。结果排除其他因素,确保高流量湿化氧疗装备的安全有效,在每天连续工作时间≤12 h时,确定其有效工作使用期限为5年。结论将加速试验理论应用到医疗器械使用期限评价中,缩短试验时间,提高试验效率,降低试验损耗。

Objective To verify the effective service life of HFNC equipment,to ensure the safety and effectiveness of users.Methods According to the two distribution principle,the sampling number was 10,and the actual effective test time was 22 h,per day lasted 30 days.Based on the basis of life test,the acceleration life model is used to accelerate the event compression and stress acceleration to evaluate the reliability under normal working stress.Results Eliminate other factors and ensure the safe and effective duration of high-flow wet oxygen therapy equipment,determined at≤12 h per day.Conclusion Accelerating test theory is applied to the evaluation of medical device to shorten test time,improve test efficiency and reduce test loss.