中国标准化Issue(17)：204-208,5.DOI:10.3969/j.issn.1002-5944.2025.17.032
医疗器械可触及部分的确定方法研究
Research on the Determination Method of Accessible Parts of Medical Devices
邓振进 1吴碧涛 1唐桂鹏 1周阳 1陈新平 1石蓉 1谢莉凤1
作者信息
摘要
Abstract
Objective:From the perspective of medical device safety,the accessible parts are accurately and completely found,and the leakage current flowing into or out of these accessible parts or flowing between these accessible parts is measured,ensuring that it does not exceed the specified limit of the contact current.Method:Through risk analysis and research on standards,examples are put forward to analyze the determination and test methods of accessible parts.Result:It can help the testing institutions and the manufacturing enterprises to effectively and accurately identify the accessible parts,eliminate potential safety risks in medical devices,and ensure that the products comply with the relevant safety standards.Conclusion:Only with an in-depth and comprehensive understanding of the standards development background and a clear understanding of the electrical structure of the tested equipment through structural inspection,can one accurately and completely find the accessible parts.This paper provides guidance and reference for medical device testing institutions and manufacturers.关键词
可触及部分/接触电流/正常使用/正常条件/单一故障条件Key words
accessible parts/touch current/normal use/normal condition/single fault condition引用本文复制引用
邓振进,吴碧涛,唐桂鹏,周阳,陈新平,石蓉,谢莉凤..医疗器械可触及部分的确定方法研究[J].中国标准化,2025,(17):204-208,5.
