Medical equipment testing refers to people performing real-time or non-real-time qualitative testing and measurement in the fields of production, experimentation, scientific research, use, maintenance, etc. with the help of specialized instruments and equipment in order to obtain the work and rest of the tested and controlled objects in time. A process of testing reports. In the process of using medical equipment, we need continuous testing and evaluation to ensure its normal work, so that medical equipment can make better use of its advantages. Therefore, daily monitoring of medical equipment is essential.
Five elements of detection
The five elements of medical equipment testing include: testing standards, testing equipment, testing personnel, testing objects, and testing reports.
Medical equipment testing standards are divided into national standards, industry standards and registered product standards.
(1) National standards or industry standards refer to standards that require uniform technical requirements across the country.
(2) The registered product standard refers to the product standard established by the manufacturer, which should ensure that the product is safe and effective, and when the product is applied for registration, it is reviewed by the drug supervision and administration department at or above the municipal level in the district according to the relevant requirements of national standards and industry standards.
There are many types of testing equipment, basically involving various subject areas. The following are 10 basic categories of medical equipment testing instruments:
Geometric measurement: such as meter ruler. 2. Temperature measurement: such as thermocouple thermometer, semiconductor thermistor thermometer, liquid crystal thermometer, infrared thermal imaging thermometer, etc. 3. Mechanical measurement: such as balance, weight, weight scale. 4. Electromagnetic measurement: such as ammeter, voltmeter, capacitance meter, etc. 5. Stoichiometry: such as photoelectric colorimeter, spectrophotometer, acidity meter, electrophoresis instrument, quality analyzer, oxygen meter, trace gas analyzer, etc. 6. Optical metrology: such as measuring electron microscope and illuminance meter. 7. Acoustic measurement: such as audiometer, spectrum analyzer, decibel meter, etc. 8. Electronic measurement: such as ECG measurement and EEG measurement. 9. Time frequency measurement: such as timers and stopwatches. 10. Ionizing radiation metering: such as medical activity measuring device, R-ray detector, X-ray meter, dosimeter, dose equivalent meter, neutron ray meter, exposure meter, etc.
Medical equipment testing personnel should have received relevant training to understand the testing indicators of the tested equipment and relevant national laws and regulations on medical equipment testing
Medical equipment is an important symbol of modernization, the most basic element of medical, scientific research, teaching and research, and teaching. It is also a basic condition for continuous improvement of medical science and technology. Medical equipment in a broad sense includes medical devices, home medical equipment, and professional medical equipment It does not include household medical equipment. Medical equipment refers to instruments, equipment, utensils, materials, or other items used alone or in combination in the human body, including the required software; their use on the surface and in vivo of the human body is not obtained by means of pharmacology, immunology, or metabolism, but These methods may participate and play a certain auxiliary role. Medical equipment can be generally divided into three categories according to the nature of its measurement object:
Medical detection equipment, monitoring equipment or automatic analysis and diagnosis system for measuring or monitoring the physical or chemical quantities in the human body. For example, electrocardiograph, electroencephalograph, impedance blood flow meter, electrooculograph, monitor, etc. Medical equipment used to measure or monitor the degree of response of the human body system to the absorption, reflection, attenuation, etc. of external signal sources, indirectly measure or monitor the physiological and pathological parameters of the human body . Such as X-ray machine, CT machine, B ultrasound, angiography machine, etc. Therapeutic instrument or automatic therapeutic device used for therapy, measuring or monitoring its dose safety threshold. Such as various physiotherapy machines, laser knives, high-pressure defibrillators, workers' heart-lung machines, myoelectric control artificial prostheses, etc.
The quality inspection of medical equipment before, after repair or in use, the statistics of the qualified number of medical equipment is the written proof of the quality of the equipment. It is obtained through the quality inspection of products and equipment, and is the standard for guaranteeing the product quality system.
Only after regular and irregular can the medical equipment ensure the accuracy of the medical value and the unity of the unit, and the safety and effectiveness of use. Otherwise, it is difficult to ensure the correctness of clinical diagnosis and treatment using medical equipment that is not sure or even has measurement inaccuracy and excessive errors. The quality assurance and control of medical equipment penetrates into all aspects of medical equipment management. The accuracy of its measurement results is always a key issue for the quality of control equipment, and medical metrology is an important technical foundation for ensuring the accuracy and reliability of medical equipment.
Development of international medical equipment testing
In the 1970s, the metrology work of laboratory medicine started internationally. In 1976, the United States issued the "Medical Device Amendment", and the Food and Drug Administration (FDA) is responsible for the safety management of medical equipment. In 1990, the United States promulgated the "Medical Device Safety Law" to regulate the safety of medical devices in accordance with the law. On this basis, the hospital has successively incorporated the quality of medical equipment into medical quality management, and has established relevant systems, qualifications and quality control standards. In 2003, the International Bureau of Metrology 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.
Due to the accelerated pace of modernization in countries around the world, the requirements for inspection technology are becoming higher and higher, especially the rapid progress of large-scale integrated circuit technology, microcomputer technology, mechatronics technology, nanotechnology and new material technology, which greatly promotes modern inspection technology development of. The general trend of the development of modern detection technology generally includes the following aspects.
Expand the measurement range and improve the detection accuracy and reliability.
The sensor is developing towards integration, multi-function and integration.
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 detection systems generally have the functions of system failure self-test, self-diagnosis, self-zeroing, self-calibration, self-selection range, automatic test and automatic sorting.
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