体外诊断(IVD)医用设备中激光源辐射类别的评估流程

Evaluation Process of Laser Radiation Category in In Vitro Diagnostic(IVD)Medical Equipment

在体外诊断(IVD)医用设备的电气安全标准GB 4793.1-2007中提出对涉及到使用激光源的时候应当满足GB 7247.1-2012《激光产品的安全第1部分:设备分类、要求》的要求。尽管这类设备的激光源一般是在设备内部且不对外发射,但如不注意激光,对操作/维护人员的危害又是极大的。故正确的激光分类可对操作/维护人员起到警示等作用,减少因人员疏忽带来的危害。文章主要对体外诊断(IVD)设备中激光源在GB 7247.1-2012中分类过程进行梳理,以更好地快速进行分类判断。

In the electrical safety standard for in vitro diagnostic(IVD)medical equipment GB 4793.1-2007,it is proposed that the use of laser sources should meet GB 7247.1-2012“Safety of Laser Products Part 1:Equipment Classification and Requirements”requirements.Although the laser source of this type of equipment is generally inside the equipment and does not emit to the outside,if the laser is not paid attention to,the harm to the operation/maintenance personnel is great.Therefore,the correct laser classification serves as a warning for operation/maintenance personnel,and reduces the harm caused by personnel negligence.This article mainly sorts out the classification process of laser sources in in vitro diagnostic(IVD)equipment in GB 7247.1-2012 to help judge better and faster classification.