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Full Description

Provides guidance on the application of parts of the ANSI/AAMI/ISO 10993 series of standards to the biological evaluation of medical devices that have been sterilized with ethylene oxide. This TIR primarily addresses evaluation of devices according to ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals, but limited guidance is also given for other parts of the ANSI/AAMI/ISO 10993 series. Companion to ANSI/AAMI/ISO 10993-7.
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO TIR19/A1:1999


    Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals