This article introduces the current status of Chinese institutes for medical devices testing, and analyses the misunderstanding in extending the testing capacities for the provincial institutes for medical devices. Then, some suggestions are given to orientate themselves in extending capacities. Finally, these specific procedures on extending the testing capacities are presented.
China ; Equipment and Supplies ; standards

Based on the analysis of Chinese medical device standardization situation, providing recommendations for the development strategy of Chinese medical device standardization proceed from the duty and advantage of standardized participation.
China ; Equipment and Supplies ; standards

Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.
Equipment and Supplies ; standards

This paper analyses overall situation of the national quality inspection for medical devices in recent 13 years. The statistics cover the inspected varieties, sampling quantity and quality status. The achievements and suggestions are provided, which are helpful for future work.
Equipment and Supplies ; standards ; Humans

By research on the universal standards classification of medical device, according to their functions and scope of application, they are divided into two levels, universal standard architecture is proposed, to provide opinions and suggestions for standard system construction of medical devices.
Equipment and Supplies ; standards ; Humans

The paper introduces the background of YY/T 0841 standard, and interprets the main content of this standard. It is helpful to understand and applicate the standard.
Electrical Equipment and Supplies ; standards

Through the analysis of the present problems of the quality of medical device standards in China, combined with the development trend of the last ten years of medical devices, the paper made proposals on the medical device standards quality evaluation system, so as to improve the medical device standards management level and the quality of medical device standard in our country.
China ; Equipment and Supplies ; standards

In this paper, Medical Device Standards, including Nation standards and Professional standards are investigated. The major problems that may appear in the Medical Device Standardization are analyzed. Based on the result of the analysis, some policy suggestions on the medical device standardization are put forward, which may help the authority making policy of standardization in Medical Device.
China ; Equipment and Supplies ; standards

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

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards