
Aseptic Processing Of Health Care Products - Part 1: General Requirements (Iso 13408-1:2008, Including Amd 1:2013)
出版:Standardiserings-Kommissionen I Sverige

專家解讀視頻
基本信息
標準編號: SS EN ISO 13408-1 Ed. 2 (2015)
標準類別:Standard
出版單位:Standardiserings-Kommissionen I Sverige
標準頁數:72
標準簡介
Defines the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
標準備注
Supersedes SS EN 13824. (08/2011)
本標準替代的舊標準
等同采用的國際標準
EN ISO 13408-1:2015 - Identical