医疗器械电磁兼容标准中对随机文件的编写要求  

Compiling Requirement for Accompanying Documents of Medical Equipment in EMC Standards

作　　者：缪佳 

机构地区：[1]江苏省医疗器械检验所,南京210012

出　　处：《中国医疗器械信息》2013年第5期38-40,48,共4页China Medical Device Information

摘　　要：结合YY0505、GB/T18268.1及GB/T18268.26标准中对随机文件的要求,介绍了医疗器械电磁兼容标准中对随机文件的规定,举例介绍了医疗器械制造商如何编写产品随机文件的相应内容。Combining the requirements of accompanying file in YY0505, GB/T 18268.1 and GB/T18268.26 standard. Describes the compiling requirements for accompanying documents of medical equipment in EMC standards. Examples to introduce how to manuthcturers of medical devices to prepare the eorresponding content product accompanying documents.

关 键 词：医疗器械 电磁兼容 随机文件 编写 

分 类 号：R312[医药卫生—基础医学]