"Medical three sources" is a mandatory verification of measuring instruments?
Conclusion of the "People's Republic of China *** and the State Measuring Instrument Certification Management Measures" (issued by the State Council, administrative regulations are more effective than departmental regulations) will be "three sources of medical" included in the "mandatory inspection of measuring instruments catalog". 1998, the Ministry of Health, the State Bureau of Technical Supervision issued a joint "on the use of medical units and the implementation of inspection notice of mandatory inspection of measuring instruments" (Health Science and Education Development [1998] No. 6), clearly "medical radiation" is a "mandatory verification of measuring instruments Notice on the implementation of the inspection of medical units using mandatory testing of measuring instruments and their management" (Health Science and Education [1998] No. 6), clearly "medical radiation sources", "medical laser sources" and "medical ultrasound sources" as a mandatory The inspection of measuring instruments into the scope of the inspection program, the implementation of the inspection. Therefore, the medical three sources of medical mandatory verification of measuring instruments, quality supervision departments should be implemented in accordance with the mandatory verification. Reason "medical three sources" are measuring instruments. From the "medical three sources" itself the nature of the "Measurement Law Implementing Rules" on the "measuring instruments" definition has a clear description, measuring instruments can be used to directly or indirectly measure the measured object value of the device, instrumentation, gauges and for the unification of the value of the Standard substances. Medical X-ray machines, ultrasound machines, laser therapy machines and other equipment, respectively, through the built-in medical radiation source, ultrasound source, laser source to measure the human body's physiological and pathological conditions, and based on the control of the output energy to achieve the purpose of diagnosis and treatment. According to the definition of measuring instruments, medical diagnostic and therapeutic equipment contained in the "medical three sources" should be measuring instruments. Requirements of the State Administration of Quality Supervision, Inspection and Quarantine has issued a number of documents, clear requirements: the manufacture of medical ultrasound, laser and radiation source products must be handled for the manufacture of measuring instruments license, the use of such products must be mandatory calibration. Manufacturing with medical ultrasound, laser or radiation source with diagnostic instruments (or therapeutic instrument) do not need to apply for a license for the manufacture of measuring instruments, and does not require the medical ultrasound, laser or radiation source for the manufacture of measuring instruments license, but diagnostic instruments (or therapeutic instrument) in the medical ultrasound, laser or radiation source must be mandatory calibration, before use.