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AAMI - TIR15

Physical aspects of ethylene oxide sterilization

inactive
Organization: AAMI
Publication Date: 1 January 2009
Status: inactive
Page Count: 36
scope:

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 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.

Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008

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:
TIR28 - Product adoption and process equivalence for ethylene oxide sterilization
Published by AAMI on January 1, 2016
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the...
This document references:
21 CFR PART 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Published by HHS on April 1, 2020
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be...
This document references:
21 CFR PART 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Published by HHS on April 1, 2015
A description is not available for this item.
This document references:
21 CFR PART 200 - GENERAL
Published by HHS on April 1, 2017
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:
49 CFR PART 172 - HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, TRAINING REQUIREMENTS, AND SECURITY PLANS
Published by DOT on October 1, 2022
Purpose and scope. This part lists and classifies those materials which the Department has designated as hazardous materials for purposes of transportation and prescribes the requirements for...
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:
TIR28 - Product adoption and process equivalence for ethylene oxide sterilization
Published by AAMI on January 1, 2016
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the...
This document is referenced by:
TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by ISO on November 1, 2021
This document 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 11607-1 and ISO...
This document is referenced by:
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 November 30, 2021
A description is not available for this item.
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