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I.S. EN ISO 13408-7:2015現(xiàn)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

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基本信息
標(biāo)準(zhǔn)編號(hào)： I.S. EN ISO 13408-7:2015
發(fā)布時(shí)間：2015/8/22 0:00:00
標(biāo)準(zhǔn)類別：Standard
出版單位：National Standards Authority of Ireland
標(biāo)準(zhǔn)頁(yè)數(shù)：36
標(biāo)準(zhǔn)簡(jiǎn)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.

等同采用的國(guó)際標(biāo)準(zhǔn)

ISO 13408-7 : 2012(R2018) - Identical

EN ISO 13408-7 : 2015 - Identical

EN ISO 13408-7:2015 - Identical