Résumé
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.