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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