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AAMI ISO 11607 Ed. 2 (2000)被替代

Packaging For Terminally Sterilized Medical Devices

出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI ISO 11607 Ed. 2 (2000)
发布时间:2003/3/27 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:19
标准简介

Defines requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities. Also includes the principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices and requirements for essential criteria used to evaluate the performance of the package used to protect device components during handling, distribution, and storage.

等同采用的国际标准

ISO 11607:2003 - Identical