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1. &nbsp; &nbsp; ISO 11135: 2014 &ndash;Sterilization of Health-care Product
2. &nbsp; &nbsp; EN 1422: 2014 -Ethylene oxide sterilizers
3. &nbsp; &nbsp; ISO 13485 -Quality Management for Medical Devices
4. &nbsp; &nbsp; ISO 11138-2: 2017 -Sterilization of health care products
5. &nbsp; &nbsp; ISO 10993-7: 2008 - Ethylene oxide sterilization residuals
6. &nbsp; &nbsp; AAMI TIR28: 2016-Product Adoption and Process Equivalence for Ethylene Oxide Sterilization Standard From SAI Global.
7. &nbsp; &nbsp; AAMI TIR16: 2017- Microbiological Aspects Of Ethylene Oxide Sterilization
8. &nbsp; &nbsp; ISO 11139: 2018(en) - Sterilization of health care products &mdash; Vocabulary of terms used in sterilization and related equipment and process standards
9. &nbsp; &nbsp; ISO 11737-1: 2006 - Sterilization of medical devices
10. &nbsp;ISO 14937: 2009
11. &nbsp;Sterilization of health care products &mdash; General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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ETO Sterilization Validation Regulatory Requirements

Publish Time：2023-10-10