RESUMO
In order to help the IVD medical equipment manufacturers to establish the service life of products scientifically, we analyze the main factors that may affect the service life of IVD medical equipment in accordance with the guiding principles for technical review of active medical devices issued by the center of medical device evaluation of NMPA, and focuse on an evaluation method of accelerated fatigue test, in order to standardize and guide the IVD medical equipment manufacturers to evaluate and formulate the product service life scientifically.
RESUMO
A comparison test on the number of puncture coring is conducted using the normal needle and the Huber needle in the injection area of the implantable drug-supplying device separately. The result indicates that the number of coring using the Huber needle is much less than that using the normal needle during the puncturing. So it is suggested to popularize the Huber needle in the drug transfusion of the implantable drug-supplying device.