红外线治疗设备检验问题分析研究

      Analysis and Study in Testing of Infrared Therapy Equipment

      • 摘要: 该文结合YY 0306—2008《热辐射类治疗设备安全专用要求》、GB 9706.1—2007《医用电气设备第一部分:安全专用要求》、《红外线治疗设备技术审查指导原则》等国行标及指导原则对红外线治疗设备注册及监督检验中经常遇到的问题进行了归纳总结。文章分别对分类及适用标准、性能指标、机械危险防护及超温防护等方面进行分析探讨,并对整改率较高的项目给出了一些建议及解决方法,旨在给医疗器械企业在设计、研发、注册等环节提供一些指导,有效地规避所述问题,提高检验通过率。

         

        Abstract: 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.

         

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