ANSI AAMI ST24:1999/(R)2013

Standard Organization:

ANSI AAMI ST24:1999/(R)2013
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.

Recognition Date2014-07-09
Recognition List036
Recognition Number14-290
Extent Complete standard
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STG Sterility
FDA Tech  Steven Turtil   FDA/OMPT/CDRH/ODE/DOD/PSDB/   301-796-6305   steven.turtil@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.6860 Sterilizer, Ethylene-Oxide Gas Class 2 FLF

FDA Guidance:

Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, March 1993.

Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, September 1995.

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