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Medical science regulation need technical support
Do you know? Medical equipment emc test is required, a infusion after five days and five nights precision inspection, orthopaedic stent implantation in the human body needs millions of times tensile fatigue tests, even the most common surgical masks to by professional equipment to detect filtration efficiency pounds (particle filter efficiency), March 26, to be held in Beijing medical apparatus and instruments, inspection "medical device testing institutions Open Day activities", the National People's Congress, CPPCC member, Beijing municipal people's congress, CPPCC member and nearly from colleges and universities, hospitals, communities, social organizations and other consumer representatives and various media, and medical equipment inspection to a "close contact".
Promote social use machinery safety awareness
According to introducing, the Open Day for ordinary people and government quality supervision technology support organization, zero distance contact, let the social from all walks of life to further understand the medical equipment product quality testing this high-profile and mysterious field. The campaign to "standard, inspection, security" as the theme, by the administration of state food and drug supervision and administration of medical devices and supervision organization, the Beijing municipal food and drug administration to undertake, is Beijing medical instrument examination center since its establishment in the first "Open Day" activity.
"Medical devices quality is related to people's health and life security, to do a good job of medical device supervision is an important food and drug supervision and administration department responsibilities." Administration of state food and drug supervision and administration of medical device regulatory chief priests of the male, points out that will strengthen the communication with the social from all walks of life, the knowledge of the popularization of medical equipment, promote the basic common sense of medical equipment, raising public awareness of medical apparatus and instruments, increase public understanding of the medical equipment inspection, further improve the medical equipment quality safety consciousness of the whole society.
"The risk" can reduce risk
Beijing medical apparatus and instruments, inspection, director of the liu yi, said the use of medical equipment in there is the "unexpected" and "expectations". "Unexpected" improper risk by unqualified product quality, product maintenance and product caused by improper, cause harm to the user or patient; and the "risk" is refers to the products under the normal use of the inevitable side effects caused by the product function. "The purpose of test is to find problems arising from the products in the design or use, put an end to the expected risk. Improvement of product design, reduce the risk."
In Beijing medical instrument examination center, the reporter sees ultrasonic inspection room, electrophysiological testing room, material physics laboratory, masks or lab, radiation product inspection area, electromagnetic compatibility testing laboratories and dynamic mechanics laboratory key professional testing laboratory and other modern equipment, such as close to inspect the laboratory analysis all kinds of advanced testing instruments, and watched the PFE surgical masks filter efficiency, the femoral handle with spinal internal fixator fatigue test, output system comprehensive performance testing, medical electrical equipment radiation emission test, ultra sound test, multi-parameter monitor performance test and CT performance test and so on seven is relatively close to the life of the people of the medical instrument, the equipment is in order to ensure the quality and safety of medical equipment products, effective and convenient for the product to use to provide a scientific appraisal.
Four big functions to ensure the safety of detection
Li said the Beijing municipal people's congress, the state food and drug supervision and administration bureau attaches great importance to the development of the inspection institution, repeating the medical equipment safety work, must rely on scientific and technological methods to strengthen the examination system of technical support to implement the scientific supervision, which requires the testing agencies give full play to the functions of the big four - administrative supervision of technical support, marketing and technical supervision function, technology to guarantee the quality and safety, and industrial development of technical services.
It is understood that in recent years, China's medical equipment product development in 2013 annual output value reached more than 4000 one hundred million yuan of medical equipment. At present, China's medical equipment market has become the world's third largest after the United States and Japan medical equipment market. Expert analysis, China's medical equipment market will further expand, this requires our country's medical examination institutions must strengthen own construction, seize the opportunity, meet the challenge.