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This document outlines proper microbiological methods for obtaining data necessary to control the manufacture and sterilization of medical devices. Subjects addressed in this document include the sampling of devices, the concept of sample item portion (SIP), media preparation, bioburden methods, sterility test methods for validation, validation of bioburden and sterility test methods, and environmental control and monitoring.

Product Details

Published:

07/01/1991

ISBN(s):

0910275602

Number of Pages:

21

File Size:

1 file , 1.2 MB

Note:

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