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45 FR 69682, Oct. 21, 1980, unless otherwise noted.
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Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.
(b) Classification. Class II (performance standards).