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ANSI/AAMI/ISO 13408-6:2005 (R2013)/A1:2013

Aseptic processing of health care products - Part 6: Isolator systems (Includes Amendment 1)

Specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

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Association for the Advancement of Medical Instrumentation [aami]

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