Historical
ANSI/AAMI/ISO 13408-1:2008 (R2011)
Aseptic processing of health care products - Part 1: General requirements
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]