This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.
Equipment Safety

IMDRF revised the
Equipment Safety ; Equipment and Supplies

This article presents some suggestions about how to strengthen the management of medical devices so as to remove the hidden perils and risks of medical safety.
Equipment Safety ; Equipment and Supplies ; Safety Management

China ; Equipment Safety ; Equipment and Supplies ; Safety Management

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

Micro-syringe as a result of the high frequency of clinical use, direct contact with patients, the failure of its equipment will have a direct impact on the patient's disease status. Researchers in this paper, by simulating the test fluid, electrical safety testing and analysis of statistical methods such as maintenance records, consider six kinds of common injection pump, in terms of performance, safety and the failure rate of three performance. Compared the performance analysis, summarized the various types of injection pump characteristics, researchers make suggestions to clinical departments, equipment procurement and equipment management departments for usage and improvement.
Equipment Failure ; Equipment Safety ; Syringes

An auto-retractable self-disable safety syringe is introduced. The product mainly consists of barrel, plunger hander, needle holder, spring and needle cap. After injection, the clasp on top of plunger hander will be jammed with the outshoot of needle holder, meanwhile, the plunger hander tip expands the stop structure and consequently the compression spring pulls the needle and needle holder back into plunger hander. The technical parameters of present syringe such as break force, needle holder push out force and plunger hander lock force are very stable while working. With simple structure, reasonable design, easy manufacture and assemble, this product can been widely used in relevant area.
Disposable Equipment ; Equipment Design ; Equipment Safety ; Syringes

Optical radiation hazards and the evaluation method of optical radiation safety of laser medical equipment are introduced in this paper. According to the requirement of YY/T 0316-2008, the corresponding solutions of safety control are put forward in this paper to minimize the risk of optical radiation, making sure the safety and effectiveness of laser medical equipment.
Equipment Safety ; Lasers

This article summarizes the common problems in registration and supervision testing of infrared therapy equipment, combines YY 0306-2008 Particular requirements for the safety of heat radiation therapy equipment, GB 9706.1-2007 Medical electrical equipment-Part 1:General requirements for safety, Registration technical review guidelines for infrared treatment equipment, etc. This paper analyzes and discusses the following aspects, including classification and applicable standards, performance indicators and overtemperature protection. Some suggestions and solutions are given to provide some guidance for medical equipment manufacturers in design, research and development and registration, in order to avoid the problem effectively and improve the passing rate of testing.
Electricity ; Equipment Design ; Equipment Safety ; Infrared Rays

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