China ; Laboratories ; standards ; Microbiology ; Safety Management

Medical equipment is important means and powerful tool in using for disease prevention, diagnosis, treatment, care and rehabilitation. It is widely used in clinical medicine and daily life. But, the relevant laws and regulations and technical capacity is lagging behind, resulted in their use of the process may cause harm to patients. In this paper, Guangdong Medical Devices Quality Surveillance and Test Institute found the the problems in testing of medical devices in use in guangzhou city and in other areas of guangdong province four years and summarizes, provide advice how to strengthen and improve in the regulation of medical devices in the future.
Equipment and Supplies ; standards ; Quality Control ; Safety Management

Blood Banks ; standards ; Blood Transfusion ; standards ; Humans ; Safety Management ; Singapore

Biological Products ; standards ; China ; Clinical Laboratory Techniques ; instrumentation ; standards ; Laboratories ; standards ; Safety Management ; legislation & jurisprudence ; standards

This article describes the measure to decrease the emission of a domestic infusion pump which can't pass the radiated emission test when performing EMC tests. Then optimizes the measure and evaluates whether these measures affect the original electrical safety of the pump.
Electricity ; Infusion Pumps ; standards ; Quality Control ; Safety Management

Consumer Product Safety ; Drinking Water ; standards ; Equipment Safety ; Food Safety ; Public Health ; instrumentation ; methods ; Safety Management ; Water Supply

Preventive maintenance of medical equipment can be helpful in improving the efficiency of medical devices, establishing a standardized management and plan, a classification of maintenance of medical devices, inspection tour of devices and operating condition of dynamic monitoring devices. It has benefit in prolonging the useful life of medical devices, reducing maintenance cost and improving management and service quality.
Equipment Safety ; methods ; Equipment and Supplies ; standards ; Maintenance ; Maintenance and Engineering, Hospital ; Safety Management ; methods

In clinical practice, incubators can contribute to better diagnosis and treatment of diseases. Currently, insulation medical equipment used for the newborn are mainly warm-boxes. With the use popularity of warm-boxes in the country, medical accidents caused by improper use are on the increase. According to neonatal insulation technology and standardized management of practice, this article puts forward technical requirements of infant incubators with constant temperature and humidity, operation regulations and management specifications to better regulate the use of such devices. Meanwhile, it also suggests national related departments to formulate "incubator technology management norms" and "warm-box technology and practice", intending to standardize industry behaviors and ensure medical safety.
Humans ; Incubators, Infant ; standards ; Infant, Newborn ; Materials Management, Hospital ; organization & administration ; Safety Management ; Temperature

Safety and effectiveness of medical devices is a focus of people's attention, which is also a central work for the government's administration. Carrying out safety standards of medical devices, implementing the quality system standards and risk management standards are supplemented with each other. The risk management is an indispensable part to the quality management system of medical devices.
Equipment Failure Analysis ; Equipment Safety ; methods ; standards ; Equipment and Supplies ; standards ; Humans ; Product Surveillance, Postmarketing ; methods ; Risk Assessment ; Risk Factors ; Risk Management ; Safety Management

Biological evaluation of medical devices before clinical usage has become one of the necessary procedure. But many of medical devices which have already passed a series of biological safety evaluation do not mean that they are absolutely safe and harmless. And there are still application risks in these medical devices, because of the deficient knowledge about the interaction of biomedical materials and human tissue, limitation of the existent technology level, the indefiniteness of the evaluation system, the imperfections of present standards and so on. This essay is trying to analyze the relationship between the biological evaluation of medical devices and their application risks, and to discuss how to make a risk analysis related to biological evaluation in order to acquire a better and exact understanding of biological evaluation for medical devices.
Device Approval ; standards ; Equipment Safety ; standards ; Equipment and Supplies ; standards ; Humans ; Materials Testing ; Reference Standards ; Risk Management ; Technology Assessment, Biomedical ; methods ; standards ; Toxicity Tests