AAMI TIR29-2012
Guide for process characterization and control in radiation sterilization of medical devices

Standard No.

AAMI TIR29-2012

Release Date

2012

Published By

US-AAMI

Latest

AAMI TIR29-2012

Scope

This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.

AAMI TIR29-2012 history

• 1970 AAMI TIR29:2012 Technical Information Report Guide for process characterization and control in radiation sterilization of medical devices
• 1970 AAMI TIR29:2002 Guide for process control in radiation sterilization