无菌医疗包装是无菌医疗器械安全的基本保证

The Sterile Barrier System is Essential to Ensure the Safety of Terminally Sterilized Medical Devices

无菌医疗包装(无菌屏障系统)是无菌医疗器械的一个关键的且不可分割的组成部分,是无菌医疗器械及医患人员安全的基本保证。有效的无菌包装系统是确保医疗器械的安全性与有效性、减少医疗相关性感染的发生、保护患者与医护人员的健康与生活的第一道防线。本文概述了无菌包装的发展历程,工程中设计生产的因素及其将来的发展与展望,从国际和国内的行业标准的角度叙述了无菌包装的关键热点。

The Sterile barrier system is essential to ensure the safety of terminaly sterilized medical devices, is also the defense line for the patients and healthcare workers. The effective sterile barrier packaging system ensure medical device products safe and efifcacious, reduce the possibility of HAI, protect people’s life and healthy. In this article, we review the history of sterilize packaging system development, discuss the most important issues from the engineering development standpoint. Summarize the outlook of sterile packaging industry future. Also discuss some hot topics from international and domestic regulations.