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Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G - GENERAL HOSPITAL AND PERSONAL USE MISCELLANEOUS DEVICES
Section 880.6880 - Steam sterilizer

21 C.F.R. § 880.6880

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Current through September 30, 2024
Section 880.6880 - Steam sterilizer
(a)Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
(b)Classification. Class II (performance standards).

21 C.F.R. §880.6880


  • Section 880.6870 - Dry-heat sterilizer
  • Section 880.6885 - Liquid chemical sterilants/high level disinfectants
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