I.S. EN ISO 13408-7:2015现行
Aseptic Processing of Health Care Products Part 7: Alternative Processes for Medical Devices and Combination Products (iso 13408-7:2012)
出版：National Standards Authority of Ireland
专家解读视频
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.
EN ISO 13408-7:2015 - Identical
ISO 13408-7 : 2012(R2018) - Identical
EN ISO 13408-7 : 2015 - Identical
