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BS EN ISO 13408-7 : 2015現(xiàn)行

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
標(biāo)準(zhǔn)編號(hào)： BS EN ISO 13408-7 : 2015
標(biāo)準(zhǔn)類別：Standard
出版單位：British Standards Institution
標(biāo)準(zhǔn)頁(yè)數(shù)：0
標(biāo)準(zhǔn)簡(jiǎn)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.

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

BS ISO 13408-7 : 2012

等同采用的國(guó)際標(biāo)準(zhǔn)

EN ISO 13408-7 : 2015 - Identical

ISO 13408-7 : 2012(R2018) - Identical