Detection Status

1. The development of international medical equipment testing In the 1970s, the measurement work of international laboratory medicine started. In 1976, the United States issued the "Medical Device Amendment", and the Food and Drug Administration (FDA) was responsible for the safety management of medical devices. In 1990, the United States promulgated the "Medical Device Safety Act" to supervise the safety of medical devices according to law. On this basis, hospitals have successively incorporated the quality of medical equipment use into medical quality management, and established relevant systems, qualifications and quality control standards. In 2003, the International Bureau of Weights and Measures established the "Medical Metrology Technical Advisory Committee". According to the objectives and principles of the WTO/TBT agreement, the government is required to pay attention to medical measurement and the safety of medical equipment.

2. The development of medical metrology in China

Compared with the international medical metrology work, China's reference system started relatively late, and its technical accumulation is relatively not advanced enough, such as insufficient medical testing standard equipment, and weak professional technical force in medical metrology. Some of the testing equipment in China cannot fully meet the needs of advanced medical equipment testing for the time being. Although there is still a certain gap in the measurement work of laboratory medicine in China compared with developed countries, it is fully qualified to establish a reference system. Since 1986, the country has successively promulgated and implemented a series of supporting laws and regulations such as the "Measurement Law of the People's Republic of China", "Implementation Rules for the Metrology Law of the People's Republic of China" and "Details of Work Measuring Instruments Compulsory Verification of the People's Republic of China".

Development trend

Due to the accelerated pace of modernization in all countries in the world, the requirements for detection technology are getting higher and higher, especially the rapid progress of large-scale integrated circuit technology, microcomputer technology, mechatronics technology, nanotechnology and new material technology, which has greatly promoted The development of modern detection technology. The general trend of the development of modern detection technology generally has the following aspects.

1. Expand the measurement range and improve the detection accuracy and reliability.

2. Sensors are developing in the direction of integration, multi-function and integration.

3. Non-contact detection technology. Such as photoelectric sensors, eddy current sensors, infrared detection instruments, ultrasonic detection instruments, nuclear radiation detection instruments, etc.

Intelligent detection system. Intelligent modern medical device testing systems generally have the functions of system fault self-test, self-diagnosis, self-zeroing, self-calibration, self-selecting range, automatic testing and automatic sorting.