AAMI-TIR29 › Guide for process control in radiation sterilization
Guide for process control in radiation sterilization
Scope
This technical report provides additional guidance for establishing and meeting the irradiator dose mapping, process qualification, and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137:1994 for gamma and electron beam sterilization. Although bremsstrahlung irradiation has similar requirements, there was little experience in the design and operation of a bremsstrahlung irradiation facility at the time this work was conducted, therefore the requirements for bremsstrahlung irradiation are not included in the scope.
Notes
Claudia's Notes:
This document is the second edition of AAMI TIR29. It is now more closely aligned with the general format/section headings of ISO 11137-1 and eliminates redundancies of ISO 11137-3. This second edition is expanded to encompass process characterization and process control, address X-ray sterilization, and provide more guidance regarding additional dose mapping studies, mapping, and processing families. It also incorporates information regarding process equivalency in cobalt-60 radiation sterilization facilities.
The new 28-page 2012 Edition replaces AAMI TIR29 2002, which is now obsolete. In spite of the fact that it is aligned with the ISO 11137 series, there is no equivalent International Standard for this AAMI release. The document is cited by the FDA as relevant guidance.
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Document Number
AAMI TIR29:2012/(R)2017 [HISTORICAL]
Revision Level
2012 R17 EDITION
Status
Superseded
Publication Date
Oct. 1, 2017
Page Count
40 pages