C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart G—General Hospital and Personal Use Miscellaneous Devices

21 C.F.R. § 880.6860

Ethylene oxide gas sterilizer

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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).

Notes of Decisions
Cited in 2 cases, 1989–1999 · leading case: United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989).
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United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989). “” 21 C.F.R. § 880.6860 (1988). 16 . A dry-heat sterilizer "is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.”
United States v. Bowen, 172 F.3d 682 (9th Cir. 1999). “6850 (sterilization wrap); 21 C.F.R. § 880.6860 (ethylene oxide gas sterilizer); 21 C.”
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