Ethylene Oxide
This category is specific to sterilization with ethylene oxide. This includes standards on the general purpose, requirements and more.
ANSI/AAMI ST24:1999 (R2018)
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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.
ANSI/AAMI ST41:2008 (R2018)
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
This recommended practice covers the safe and effective use of ethylene oxide as a sterilant in health care facilities. The provisions of this document are intended to promote sterility assurance, help minimize occupational exposure to ethylene oxide, and guide health care personnel in the proper use of processing equipment.
ISO 11135:2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
AAMI TIR74:2016 (R2021)
Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Provides summary of differences between the new 2014 version and the 2007 version of ISO 11135. Provides end users with a quick reference when evaluating and implementing the 2014 version of ISO 11135 in their facilities.
AAMI TIR56:2013 (R2020)
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.
AAMI TIR14:2016 (R2020)
Contract sterilization using ethylene oxide
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
AAMI TIR15:2016 (R2020)
Physical aspects of ethylene oxide sterilization
This technical information report (TIR) provides additional guidance to augment the ANSI/AAMI/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability.
AAMI TIR16:2017 (R2020)
Microbiological aspects of ethylene oxide sterilization
Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
AAMI TIR28:2016 (R2020)
Product adoption and process equivalence for ethylene oxide sterilization
This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.
ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
