Historical
ANSI/AAMI/ISO 13408-1:2008 (R2011)/A1:2013
Aseptic processing of health care products - Part 1: General requirements (includes Amendment 1).
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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]