DIN EN ISO 13408-7 E : 2015現行
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)
專家解讀視頻
基本信息
標準編號： DIN EN ISO 13408-7 E : 2015
標準類別：Standard
出版單位：German Institute for Standardisation (Deutsches Institut für Normung)
標準頁數：0
標準簡介
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.
