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AAMI TIR15

Physical aspects of ethylene oxide sterilization

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Organization: AAMI
Publication Date: 1 January 2016
Status: active
Page Count: 37
scope:

This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration and flammability, as well as guidance on the use of statistics for process equivalence.

Document History

TIR15
January 1, 2016
Physical aspects of ethylene oxide sterilization
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on...
AAMI TIR15
January 1, 2016
Physical aspects of ethylene oxide sterilization
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on...
TIR15
January 1, 2009
Physical aspects of ethylene oxide sterilization
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135–1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on...
TIR15
January 1, 2009
Physical aspects of ethylene oxide sterilization
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135–1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on...
TIR15
January 1, 1997
Ethylene Oxide Sterilization Equipment, Process Considerations and Pertinent Calculations
A description is not available for this item.

References

This document references:
TIR16 - Microbiological aspects of ethylene oxide sterilization
Published by AAMI on January 1, 2017
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...
This document references:
21 CFR PART 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Published by HHS on April 1, 2017
A description is not available for this item.
This document references:
21 CFR PART 200 - GENERAL
Published by HHS on April 1, 2018
A description is not available for this item.
This document references:
21 CFR PART 820 - QUALITY SYSTEM REGULATION
Published by FAA on April 1, 2020
(a) Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the...
This document references:
29 CFR PART 1910 VOL 5 - OCCUPATIONAL SAFETY AND HEALTH STANDARDS
Published by DOL on July 1, 2021
Purpose and scope. (a) Section 6(a) of the Williams- Steiger Occupational Safety and Health Act of 1970 (84 Stat. 1593) provides that ‘‘without regard to chapter 5 of title 5, United States Code, or...
This document references:
40 CFR PART 63 VOL 12 - NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED)
Published by EPA on July 1, 2022
A description is not available for this item.
This document references:
TIR16 - Microbiological aspects of ethylene oxide sterilization
Published by AAMI on January 1, 2017
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...
This document is referenced by:
CSA ISO/TS 16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by CSA on January 1, 2017
This Technical Specification provides guidance for the application of the requirements contained in ISO 11607‑1 and ISO 11607‑2. It does not add to, or otherwise change, the requirements of ISO...
This document is referenced by:
BS PD CEN ISO/TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by BSI on May 31, 2014
A description is not available for this item.
This document is referenced by:
CSA Z11135 - Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by CSA on January 1, 2015
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document is referenced by:
CSA Z11135-2 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
Published by CSA on March 1, 2009
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1...
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