IEC 82304-1标准国内转化的讨论  

Discussion of Domestic Adaptation of IEC 82304-1

作　　者：侯丙营 陈蓓 李泽瑾 

机构地区：[1]北京怡和嘉业医疗科技股份有限公司,北京100043

出　　处：《中国医疗器械信息》2018年第1期25-29,66,共6页China Medical Device Information

摘　　要：医疗器械独立软件作为一个纯软件产品越来越多的被应用于疾病的诊断、治疗与医生的辅助决策,IEC62304/YY/T 0664标准并不能覆盖独立软件要求的所有方面,国内在监管上虽然已经发布相应的指导原则,但是还没有成熟的标准来更好的指导制造商开发维护独立软件。本文通过介绍IEC 82304-1标准的内容,讨论国内转化IEC 82304-1标准的必要性。Medical device independent software is a software product that being widely used in diagnostic, treatment and doctors？ decision aid. YY/T 0664-2008 Medical device software-Software life cycle processes （IEC 62034：2006, IDT） cannot cover all requirements for independent software. Even though domestic supervision has released related regulations, there is still missing a mature standard that can guide manufacture developing and maintain independent software. This article makes a brief introduction to IEC 82304-1 Health software-Part 1 general requirements for product safety and its necessity for domestic adoption.

关 键 词：医疗器械 独立软件 医疗器械软件 健康软件 健康软件产品 软件生存周期 

分 类 号：DF36[政治法律—宪法学与行政法学]