AAMI ISO 11607 Ed. 2 (2000)被替代
Packaging For Terminally Sterilized Medical Devices
出版：Association for Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： AAMI ISO 11607 Ed. 2 (2000)
發(fā)布時間：2003/3/27 0:00:00
標準類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標準頁數(shù)：19
標準簡介
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.
等同采用的國際標準
ISO 11607:2003 - Identical
