AAMI TIR 8 : 1ED 91
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERILIZATION OF MEDICAL DEVICES
09-30-1998
01-12-2013
Defines proper microbiological procedures for obtaining data necessary to control the production and sterilization of medical devices. Subjects addressed include device sampling, the concept of sample item portion (SIP), media preparation, bioburden methods, validation of bioburden and sterility test methods, and environmental control and monitoring.
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