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GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 11-09-2016
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representationForewordIntroduction1 Scope2 Terms and definitions3 Process descriptions4 Quality management systems5 Sterilizing agent characterization6 Process and Equipment Characterization7 Product definition8 Process definition9 Validation10 Routine Monitoring and Control11 Product Release from Sterilization12 Maintaining Process EffectivenessAnnexesAnnex A (informative) - Microbial Validation Using an Augmented Overkill ApproachAnnex B (informative) - Microbial Validation Using Reduced EO ConcentrationBibliography
Defines information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.
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