Objective:To test the sterile status maintenance of disposable spinal internal fixation instrument packages under simulated field conditions.Methods:Combined with the validation of ASTM D4169 standard for medical device transportation,simulate the transportation of medical devices under field conditions,and have Suzhou Fugang Industrial Testing Technology Co.,Ltd.test the outer box,inner packaging box,single packaging,and internal samples of the samples.Evaluate the effective shelf life of the sterile barrier system of the test sample before and after accelerated aging by conducting aseptic testing,visual inspection,vacuum leakage testing,dye leakage testing,microbial barrier performance testing,sealing strength and swelling test.Results:After testing,the outer box of the sample was slightly deformed and there was no damage.The appearance of the inner packaging box,single packaging,and internal samples was normal and there was no damage.After testing,the products inside the sterile barrier system remain sterile before and after accelerated aging;Visually inspect the integrity and uniformity of the entire sealing area under a magnifying glass,as well as whether there is a passage that runs through the entire sealing area;The test sample did not leak before and after accelerated aging;No dye penetration sterile barrier system sealing;The microbial barrier performance test results are satisfactory;The sealing strength of the packaging is qualified;The burst test is qualified.Conclusion:Under the conditions of this experiment,the sterile barrier system of the test sample can ensure an effective shelf life of 5 years.
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