1, the international development of medical equipment testing
In the 1970s, the international testing of medical metrology has begun. 1976, the United States issued the "Medical Device Amendments" by the Food and Drug Administration (FDA) is responsible for the safety of medical equipment management. 1990, the United States promulgated the "Medical Devices Safety Act", the law regulates the safety of medical devices. On this basis, the hospitals have incorporated the quality of medical equipment into the quality management of medical care, and have built the relevant systems, qualifications and quality control standards. 2003, the International Bureau of Weights and Measures set up the "Medical Metrology Technical Advisory Committee". According to the target principle of WTO/TBT agreement, the government is required to pay attention to medical measurement and medical equipment safety.
2, China's medical metrology development
International medical metrology work, China's reference system started late, the accumulation of technology is relatively less advanced, such as the medical special detection of the lack of standardized instruments, medical measurement of professional and technical strength is weak. Domestic part of the calibration equipment, but also temporarily unable to fully meet the needs of advanced medical equipment testing work. Although China's test medical measurement work compared with developed countries there is still a certain gap, but has been fully equipped to carry out the establishment of the reference system. Since 1986, the state has promulgated and implemented the "Chinese People's **** and State Measurement Law", "Chinese People's **** and State Measurement Law Implementing Rules" and "Chinese People's **** and State Compulsory Certification of the work of measuring instruments detailed list" and a series of supporting laws and regulations.