Donawa M E
Donawa and Associates Ltd, Rome, Italy.
Med Device Technol. 1997 Jul-Aug;8(6):10-2.
Manufacturers of terminally sterilized medical devices must ensure that packaging protects the device from damage, allows it to be sterilized, and provides an effective barrier against microbiological contamination. The previous article in this column discussed quality system requirements for packaging. Recently, an international standard concerning sterile packaging has been developed and this article provides an overview of the standard.
最终灭菌医疗器械制造商必须确保包装能保护器械不受损坏，使其能够进行灭菌，并提供有效的微生物污染屏障。本专栏的上一篇文章讨论了包装的质量体系要求。最近，一项关于无菌包装的国际标准已经制定出来，本文将对该标准进行概述。
