Historical

AAMI TIR56:2013 (R2016)

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought
ISO 11607 - Terminally Sterilized Medical Devices Package.
Product adoption and process equivalence for ethylene oxide sterilization
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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Amendments & Corrections
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