This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.
Document identifier
AAMI TIR28:2016
Title
Product adoption and process equivalency for ethylene oxide sterilization
AAMI Category
EO and Chemical Disinfection
Publication date
2016-11-18
International Relationship
History of version
AAMI TIR28:2016 * AAMI TIR28:2009/(R)2013 * AAMI TIR28:2001
Price |
131 vnd |