Code of Federal Regulations · Section

§ 880.6860 — Ethylene Oxide Gas Sterilizer

21 C.F.R. § 880.6860

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(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).

21 C.F.R. § 880.6850 21 C.F.R. § 880.6870

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