摘要
随着医疗器械软件在应用中的扩展,其相应标准IEC62304也成为一个重要的基础标准。然而,由于软件自身的一些规律导致了在标准的理解与实施中出现了很多疑问。欧洲公告机构组织应此形势对一些常见问题进行了收集、整理并提供了一份集中解答的文件。鉴于此文件对我国的医疗器械软件行业具有很高的学习价值,参照国内应用IEC 62304的一些情况,本文对其进行了介绍,并对其中的一些问题有选择地进行了解读。
As software gaining it＇s importance in the application of medical devices, the corresponding standard IEC62304 become a very important basic standard. However, a lot of questions raised in the understanding and during the practice of this standard. Some frequent questions were collected by NB-Team, and the answers are organized as a document. As we expecting the document is quite valuable for the Chinese medical devices industry we introduced this FAQ and made an understanding of this document.
出处
《中国医疗器械信息》
2014年第1期47-50,共4页
China Medical Device Information
