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The odor threshold for these gases is above the PELs and for ethylene oxide it is 500 ppm, approaching that of the IDLH. [1] Odor is thus inadequate as a monitoring technique. Continuous gas monitors are used as part of an overall safety program to provide a prompt alert to nearby workers in the event that there is a leak of the sterilant gas ...
Part 7: Ethylene oxide sterilization residuals Part 8: Selection of reference materials (withdrawn) Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for skin sensitization Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials (available in English only)
Ethylene oxide treatment is the most common chemical sterilization method, used for approximately 70% of total sterilizations, and for over 50% of all disposable medical devices. [ 26 ] [ 27 ] Ethylene oxide treatment is generally carried out between 30 and 60 °C (86 and 140 °F) with relative humidity above 30% and a gas concentration between ...
Ethylene oxide scrubber: After the gaseous stream from the main reactor, containing ethylene oxide (1–2%) and CO 2 (5%), is cooled, it is then passed to the ethylene oxide scrubber. Here, water is used as the scrubbing media which scrubs away majority of ethylene oxide along with some amounts of CO 2 , N 2 , CH 2 =CH 2 , CH 4 and aldehydes ...
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^2 Includes mono- and di- ethers of ethylene glycol, diethylene glycol, and triethylene glycol R−(OCH 2 CH 2) n −OR' where; n = 1, 2, or 3 R = alkyl C7 (chain of 7 carbon atoms) or less; or phenyl or alkyl substituted phenyl R' = H or alkyl C7 or less; or OR' consisting of carboxylic acid ester, sulfate, phosphate, nitrate, or sulfonate.
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ISO 11135:2014 Sterilization of health-care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices; ISO 11137 Sterilization of health care products – Radiation; ISO 11138 Sterilization of health care products - Biological indicators