
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
出版:British Standards Institution

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基本信息
标准编号: BS EN ISO 13408-7 : 2015
标准类别:Standard
出版单位:British Standards Institution
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.
本标准替代的旧标准