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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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IndustryTerm
gas concentration /
/
Technology
radiation /
aeration /
/
SocialTag
Hygiene
Health
Electron beam
Microbiology
Sterilization
Sterility assurance level
Ethylene oxide
Validation
Ethylene glycol
Chemistry