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[无菌包装]

[Sterile packaging].

作者信息

Röhm-Rodowald E, Jakimiak B

机构信息

Zakład Zwalczania Skazeń Biologicznych, Państwowego Zakładu Higieny w Warszawie.

出版信息

Przegl Epidemiol. 1998;52(1-2):171-82.

PMID:9738428
Abstract

After decontamination, cleaning, maintenance and functional testing, sterilized items must be packed suitably. The package must protect sterilized items against microbial contamination during removal from the sterilising chamber, and during storage or transport until use. The sterilized material must be packaged in suitable packaging material in accordance with the sterilising method. Sterilization packaging must conform to standards. There are not Polish standards for sterile packaging of medical devices. The article give general guidelines about: properties of sterile packaging, various national standards and European Standard, the packaging materials, general compatibility with the sterilization process which is intended to be used, general compatibility with the package forming process, and shelf life considerations.

摘要

经过去污、清洁、维护和功能测试后,灭菌物品必须进行妥善包装。包装必须在将灭菌物品从灭菌室取出期间以及储存或运输直至使用期间保护其免受微生物污染。灭菌材料必须根据灭菌方法用合适的包装材料进行包装。灭菌包装必须符合标准。波兰没有医疗器械无菌包装的标准。本文给出了关于以下方面的一般指南:无菌包装的特性、各国标准和欧洲标准、包装材料、与预期使用的灭菌过程的一般兼容性、与包装成型过程的一般兼容性以及保质期考量。

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