ORDB 510(K) STERILITY REVIEW GUIDANCE[removed]For STERILE devices: 1. Provide the sterilization method that will be used or was used [radiation, steam, EtO].

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Hygiene Health Electron beam Microbiology Sterilization Sterility assurance level Ethylene oxide Validation Ethylene glycol Chemistry Medicine Monomers		ORDB 510(K) STERILITY REVIEW GUIDANCE[removed]For STERILE devices: 1. Provide the sterilization method that will be used or was used [radiation, steam, EtO]. Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 17,11 KB Share Document on Facebook

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