如何应对环氧乙烷灭菌过程监管的变化。
How to respond to changes in the regulation of the ethylene-oxide sterilisation process.
作者信息
Young William T
机构信息
Sterigenics International Inc, Oak Brook, Illinois 60523, USA.
出版信息
Med Device Technol. 2006 Apr;17(3):12-5.
PMID:16736657
Abstract
The standards relating to ethylene-oxide sterilisation of medical devices are being revised. This article examines the implications of the changes for medical device manufacturers and advises what process innovations and other actions can be taken to ensure compliance.
摘要
与医疗器械环氧乙烷灭菌相关的标准正在修订。本文探讨了这些变化对医疗器械制造商的影响，并就可以采取哪些工艺创新及其他行动以确保合规性提出建议。
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