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ANSI/AAMI/ISO 13408-1:2023
Aseptic processing of health care products - Part 1: General requirements
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing.
Association for the Advancement of Medical Instrumentation [aami]