摘要
本文通过对风险控制理论的介绍,给出了判断哪些医疗器械产品适用YY0709-2009的建议。并结合YY0709的要求与风险控制理论阐述了报警系统分级管理的意义。对企业判断自身产品是否需要及如何满足YY0709标准的要求具有一定参考性作用。
This paper gives the advice to estimate which kind of medical device must comply with YY0709-2009 by introducing the risk management theory.It also elaborates the meaning of the priority of the alarm system.It will help the manufactures to decide whether and how that its products comply with YY0709-2009.
出处
《中国医疗器械信息》
2011年第9期30-32,共3页
China Medical Device Information
