
Aseptic Processing Of Health Care Products - Part 1: General Requirements
出版:British Standards Institution

專家解讀視頻
Describes 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.
Together with BS EN ISO 13408-2, 3, 4, 5 and 6, it supersedes BS EN 13824. (10/2011) 2011 Edition Re-Issued in June 2013 & incorporates AMD 1 2013. Supersedes 11/30250157 DC. (06/2013)
EN ISO 13408-1:2015 - Identical