1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
  6. Subpart G - General Hospital and Personal Use Miscellaneous Devices
  7. 21 CFR § 880.6860
21 CFR § 880.6860
Ethylene oxide gas sterilizer
June 25, 2020
CFR

(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).

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§ 880.6850 Sterilization wrap
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§ 880.6870 Dry-heat sterilizer

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