AAMI ISO 13408-7 : 2012(R2018)现行
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
出版：Association for the Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO 13408-7 : 2012(R2018)
标准类别：Standard
出版单位：Association for the Advancement of Medical Instrumentation
标准页数：0
标准简介
Describes requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
等同采用的国际标准
ISO 13408-7 : 2012(R2018) - Identical
