Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
SKU: SOP 7-035
The Ethylene Oxide (EO) Sterilization Validation Procedure governs the requirements for the validation, revalidation, adoption, and routine sterilization of medical devices by EO gas in accordance with ISO 11135:2014.
- ISO 11135:2014 Compliant
- TIR28:2016 Compliant
- ISO 10993-7:2008 / (R) 2012 Compliant
- ISO 13485:2016 and FDA QSR Compliant
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EO Sterilization Validation Procedure
The ISO 13485 Ethylene Oxide (EO) Sterilization Validation Procedure defines the planning and testing requirements for conducting the validation, re-validation, adoption and routine sterilization of medical devices by ethylene oxide (EO) gas in accordance with ISO 11135:2014.
EO Sterilization Validation Procedure Overview
The EO Sterilization Validation Procedure includes guidance on development of EO validation protocols including test considerations, selection of master challenge device, identification and placement of biological indicators (BI's) and more,
The procedure includes guidance on routine monitoring and instruction on how to evaluate products for adoption into an existing EO sterilization cycle. along with required documentation.
The EO Sterilization Validation Procedure also provides guidance on how to group products EO sterilization product families and the establishment of an EO processing category.
EO Sterilization Validation Procedure Compliance
The Ethylene Oxide (EO) Sterilization Validation Procedure is ISO 11135:2014, TIR28:2016, ISO 10993-7:2008/(R) 2012, FDA QSR and ISO 13485:2016 compliant.
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The Ethylene Oxide (EO) Product Adoption Protocol documents the product adoption evaluation process, per TIR28:2016, conducted when adding new medical devices into an existing EO sterilization cycle that has been previously validated.
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