医用制氧机使用期限的验证和分析及建议

Verification,Analysis and Advice of the Service Life for Medical Oxygen Generator

医用制氧机使用场合广泛,且患者群体涉及面广,因此,当其出现性能指标(氧浓度)不合格时,会发生患者不可接受的风险,严重时危及患者生命。为了验证医用制氧机在其声称使用期限内关键性能参数的符合性,该研究分析了影响制氧机电气安全、性能及功能的关键指标,提出验证使用期限的基本方法与思路,并根据制氧机的常规使用模型,制定产品的加速试验方法,对比试验前、中、后的测试结果,通过分析,寻找影响制氧机使用期限的因素,并给出改善建议。

Medical oxygen generator is used widely,involving a wide range of patients.When the performance index(oxygen concentration)is unqualified,it will cause unacceptable risks for patients,and endanger the lives of them.In order to verify the compliance of the key performance parameters of the medical oxygen generator within its expected service life,the key indicators affecting the electrical safety,performance and function of the medical oxygen generator were analyzed,and the basic methods and ideas of the service life verification were put forward.According to the conventional use model of the medical oxygen generator,the accelerated test method of the product was developed based on the test results acquired before,during and after the tests.And then,this paper analyzes and finds out the factors that affect the service life of the oxygen generator,and gives suggestions for improvement.