The Study On Evaluation Of Cell Biocompatibility Of Medical Devices

Objectives: (1) Analyze domestic status quo of cell biocompatibility for three kind of medical devices detected by us at present. (2) Introduce significance influential factor of cell biocompatibility test in order to guide production and improvement of medical device. (3) Compare the difference of two cell biocompatibility tests between viable count method and MTT method, then obtain a accurate, sensitive and economic method.Methods: (1) Collect the 388 detected results of cell biocompatibility of medical devices which were sent by 102 domestic enterprises from July, 2002 to December, 2004. According to separate criteria of ISO for medical devices, divide medical devices into surface contact material, contact material from vitro to vivo and vivo implant material and run analysis first time in our country. (2) Comparing the homogeneity sample with the different native material and testing each moity composition of sample, find the virose ingredient which generates the effect on cell biocompatibility test. (3) Carry out the cell biocompatibility test to aim directly at the same sample used by viable count method and MTT method. Through statistical analysis, we can compare accuratissime and sensitivity of two methods easily.Results: (1) From the 388 results of cell biocompatibility test, the eribble up to standard rate is 73.97%, in which the up to standard rate of surface contact material, contact material from vitro to vivo and vivo implant material is 54.05%, 68.22% and90.00% to part. The up to standard rate of each kind of sample is from 11.11% to 100% whose difference is very obvious. In all kinds of detected samples, the up to standard rate of pro ureth ductus and latex glove whose main component is lactoprene, is only 11.11% and 23.53%. Through statistical analysis, there is significant difference between lactoprene samples and free lactoprene samples. (2) On the basis of practical experience, general easy dissolution matter is key component to introduce cytotoxic effect, such as simple substance of raw material, low molecular polymer, adjunct and so on. pH, endotoxin and protein level all effect the test result uniformly. (3) Through comparing viable count method with MTT method, it is obvious that MTT method is more quickly, sensitive and less error and cycle time than viable count method. MTT method can reflect cell biocompatibility of biomaterial more exactly for offering reference to production and clinical application.Conclusions: The two third of Cell biocompatibility of medical devices is to accord with ISO 10993. But the difference of all kinds of samples is fairly great. Among the total, lactoprene samples especially outstanding are badly in need of upgrading. Besides of pH, antiseptic, bactericide and plasticizer, endotoxin and protein level also effect the test result. MTT method is a cell biocompatibility test method with bettter accuratissime, sensitiveness and reproducibility.