AAMI TIR16-2000(初始污染菌).pdf

List of Titles
Technical
Information
AAM TIR16: 2000
Report
Process development and
performance qualification for
ethylene oxide sterilization
Microbiological aspects
AAMI
Association for the
Advancement of Medical
Instrumentation
List of Title
AAMI Technical Information Report
AAM TR16: 2000
Process development and performance
qualification for ethylene oxide sterilization-
Microbiological aspects
Approved 13 March 2000 b
Association for the Advancement of Medical Instrumentation
Abstract: This AAML technical information report presents the various microbiological aspects of the
development of an ethylene oxide sterilization process and the validation of this process. This
document does not discuss the effect of the microbiological bioburden or the effect of the
environment that the product is exposed to during the manufacturing process. TIR16: 2000 is a
companion document to ANSI/AAM/SO 11135:1994
Keywords: sterlization, microbiological aspects, validation, ethylene oxide, EO, bioburden
@2000 Association for the Advancement of Medical Instrumentation HAAMR16: 2000
List of Title
AAMI Technical Information Report
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