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About This Item


Full Description

Includes amendment.

Specifies 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.

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 13408-1:2008/(R)2011/A1:2013

    Aseptic processing of health care products--Part 1: General requirements, Amendment 1