The product standards for medical devices' registration are important technical document for production and supervision. Up to now, some problems still exist in these product standards. This paper analyzes common issues according to the standard writing specifications.
Equipment Safety ; Equipment and Supplies ; standards

This paper describes photobiological hazards and the standards of photobiological safety in the application of medical devices. It analyzes and discusses the current status of the international standardization and the national standardization.
Equipment and Supplies ; standards ; Photobiology ; Safety

Cupping therapy (Hijama in Arabic) is a popular traditional treatment especially in Asia, the Middle East and Central Europe. Traditionally, cupping therapy has been one of the most used practices in Saudi Arabia. Standardization of the practice of cupping therapy is a very important step to eliminate or reduce any adverse events related to cupping. This article gives a brief illustration and highlights the important points of the first accredited Saudi Arabian standards for the safe use of cupping equipment and its applications.
Equipment Safety ; standards ; Government Regulation ; Humans ; Medicine, Traditional ; instrumentation ; methods ; standards ; Safety ; standards ; Saudi Arabia

Due to the high technology and the complexity of medical equipment, as well as to the safety and effectiveness, it determines the high requirements of the medical equipment maintenance work. This paper introduces some basic methods of medical instrument maintenance, including fault tree analysis, node method and exclusive method which are the three important methods in the medical equipment maintenance, through using these three methods for the instruments that have circuit drawings, hardware breakdown maintenance can be done easily. And this paper introduces the processing methods of some special fault conditions, in order to reduce little detours in meeting the same problems. Learning is very important for stuff just engaged in this area.
Equipment and Supplies, Hospital ; standards ; Maintenance ; methods ; Safety

China ; Laboratories ; standards ; Microbiology ; Safety Management

In this paper, we interpret the new YY/T 0841-2011 standard and contrast the difference between it and GB9706.1-2007 standard. Then, we improved the current preventive maintenance work. After the improvement, we not only have more effective detection of the electrical safety performance of all kinds of medical electrical equipment, but also reduce the workload of clinical engineers, improve efficiency, and reduce the risk of electrical shock.
Electrical Equipment and Supplies ; standards ; Equipment Safety ; Maintenance

The text analyzes the reasons of medical devices adverse events occurrence from manufacturers, medical institutions and patients. To guard against the events, the medical institutions should put emphasis on check of purchasing, informed consent, technical permission, SOP performing, the safe of medical and enhance monitoring etc.
Equipment Safety ; standards ; Equipment and Supplies ; adverse effects

The environmental test for medical electrical equipment may be interrupted by power cut or the equipment broken and so on. For the purpose of standard and valid testing, this paper puts forward a project about how to deal with the interrupted disposal of environmental test for medical electrical equipment. The project aims at the environmental requirements and test methods for GB/T 14710--93.
Electricity ; Environment ; Equipment Safety ; methods ; standards

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

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.
Equipment Safety ; Equipment and Supplies ; Industry ; Reference Standards