摘要
本文主要介绍了即将发布的2016版ISO13485标准的制修订过程、主要思路、主要变化和新版标准在实施时需关注的重点及其理解,以为2016版ISO13485标准的学习和贯彻提供参考。
The paper introduces the revision process, main idea and primary changes of ISO13485（3rd edition） standard which will be published in the first quarter of 2016, also introduces the concerns of standard implementation and understanding of it in detail, intends to provide reference for learning and implementing of ISO13485 standard.
出处
《中国医疗器械信息》
2016年第3期30-34,共5页
China Medical Device Information
