ANSI/AAMI/ISO 13408-1:2008 (R2011)

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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.

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Association for the Advancement of Medical Instrumentation [aami]

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

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ANSI/AAMI/ISO 13408-1:2008 (R2011)

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

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