AAMI TIR29:2012/(R)2017

Guide for process characterization and control in radiation sterilization of medical devices

Association for the Advancement of Medical Instrumentation , 12/31/2012

Publisher: AAMI

File Format: PDF

$129.00$259.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 12/31/2012

Published:12/31/2012

Pages:52

ISBN(s):1570204772

File Size:1 file , 500 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.