21 CFR 880.6880 — Sterilizer, Steam

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6880

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
FLESterilizer, Steam21843rd Party
PECSterilizer Automated Loading System213rd Party
Innolitics

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