Discussion on Testing and Standard of Blood Pressure Sensor at the Tip of Catheter / 中国医疗器械杂志

ABSTRACT

With the implementation of the new policy for coronary stent centralized volume purchasing in China, the blood pressure sensor at the tip of the catheter, as one of the essential medical instruments for the diagnosis and treatment of coronary artery disease, will meet the new development opportunity of the industry, a number of medical device companies will actively participate in the development and registration of the catheter tip blood pressure sensor. As an invasive blood pressure sensor, the catheter tip blood pressure sensor should meet the current effective industry standard YY 0781-2010, however, there are many problems when using YY 0781-2010 as a blood pressure sensor because of the difference of product structure and working mode. In this paper, the problems about "Operation Manual", "electrical performance" and "safety requirement" in the course of carrying out YY 0781- 2010 with the blood pressure sensor on the tip of catheter are discussed and analyzed in detail, hope to provide some inspiration for more research and development enterprises of blood pressure sensors on the tip of catheters and inspectors of medical device testing institutions, also hope to be able to contribute to the high-quality development of blood pressure sensor industry at the tip of the Catheter.