当前位置： 首页 > 标准详情页

ISO 13408-7 : 2012(R2018)现行

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

出版：International Organization for Standardization

获取原文如何获取原文？问客服获取原文，即可享受本标准状态变更提醒服务！

专家解读视频

基本信息

标准编号： ISO 13408-7 : 2012(R2018)

标准类别：Revision

出版单位：International Organization for Standardization

标准页数：0

标准简介

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.

本标准替代的旧标准

ISO/DIS 13408-7 : 60.00 (2012)

等同采用的国际标准

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