Influence Factor and Evaluation Discuss of IVD Medical Equipment Service Life / 中国医疗器械杂志

ABSTRACT

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.