This technical information 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 for gamma and electron beam sterilization.
Although bremsstrahlung irradiation has similar requirements, there is little experience in the
design and operation of a bremsstrahlung irradiation facility at the time of this work was initiated,
and therefore the requirements for bremsstrahlung irradiation are not included in the scope.
Document identifier
AAMI TIR29:2002
Title
Guide for process control in radiation sterilization
Publication date
2002-11-01
International Relationship
History of version
AAMI TIR29:2012/(R)2017*AAMI TIR29:2002 * AAMI TIR29:2012/(R)2017 * AAMI TIR29:2002
Price |
100 vnd |