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This technical information report provides additional guidance for characterizing the irradiationprocess and for establishing requisite process controls to ensure the irradiation system remainsin a validated state. This document is intended to complement qualification and routine controlactivities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.

Product Details

Published:

12/31/2012

ISBN(s):

1570204772

Number of Pages:

52

File Size:

1 file , 500 KB