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AAMI TIR19/A1:1999

Amendment 1 to AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Amends clause 4 to add specific guidance for blood cell separators used in donor and patient blood collection as well as related sections of TIR19:1998. Also includes editorial correction to 7.c and minor revision of A.6 to clarify intent.

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Association for the Advancement of Medical Instrumentation [aami]

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