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ISO 13408-7 : 2012(R2018)現(xiàn)行

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS

出版：International Organization for Standardization

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基本信息

標(biāo)準(zhǔn)編號(hào)： ISO 13408-7 : 2012(R2018)

標(biāo)準(zhǔn)類別：Revision

出版單位：International Organization for Standardization

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)

ISO/DIS 13408-7 : 60.00 (2012)

等同采用的國(guó)際標(biāo)準(zhǔn)

DIN EN ISO 13408-7 E : 2015 - Identical

PN EN ISO 13408-7 : 2015 - Identical

BS ISO 13408-7 : 2012 - Identical

SN EN ISO 13408-7 : 2015 - Identical

NF ISO 13408-7 : 2012 - Identical

NBN EN ISO 13408-7 : 2015 - Identical

BS EN ISO 13408-7 : 2015 - Identical

NEN EN ISO 13408-7 : 2015 - Identical

DIN EN ISO 13408-7 : 2015 - Identical