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AAMI ISO 13408-1:2008 (R2011)现行

Aseptic Processing Of Health Care Products - Part 1: General Requirements

出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI ISO 13408-1:2008 (R2011)
发布时间:2011/12/14 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:76
标准简介

Describes the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

等同采用的国际标准

ISO 13408-1:2008 - Identical

ISO 13408-1 : 2008(R2017) - Identical