AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100现行
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
出版：Association for the Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100
标准类别：Standard
出版单位：Association for the Advancement of Medical Instrumentation
标准页数：0
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(R2017) - Identical
