DIN EN ISO 13408-7 E : 2015现行
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
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基本信息
标准编号： DIN EN ISO 13408-7 E : 2015
标准类别：Standard
出版单位：German Institute for Standardisation (Deutsches Institut für Normung)
标准页数：0
标准简介
Defines 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.
