AAMI ST41 : 2008
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
Amended by
Available format(s)
Hardcopy , PDF
Superseded date
25-01-2020
Superseded by
Published date
01-01-2008
Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
Introduction: Need for the recommended practice
1 Scope
2 Definitions, symbols, and abbreviations
3 Design considerations
4 Personnel considerations
5 Receiving
6 Handling, collection, and transport of contaminated
items
7 Cleaning and other decontamination processes
8 Packaging, preparation, and sterilization
9 Installation, venting, routine care, and maintenance
of EO sterilization and aeration equipment and EO
gas sources
10 Quality control
11 Environmental and employee monitoring
Annexes
Annex A (Informative) - Occupational exposure to
ethylene oxide, final standard
(29 CFR 1910.1047)
Annex B (Informative) - Ethylene oxide and
hydrochlorofluorocarbon emission
control technologies
Annex C (Informative) - Processing CJD-contaminated
patient care equipment and
environmental surfaces
Annex D (Informative) - Selection and use of chemical
disinfectants
Annex E (Informative) - User verification of cleaning
processes
Annex F (Informative) - Thermal disinfection
Annex G (Informative) - Devices returned to the manufacturer
Annex H (Informative) - Round-robin study of the PCD
(routine BI test pack)
Annex I (Informative) - Development of a prepurchase
evaluation protocol for rigid
sterilization container systems
Annex J (Informative) - Selecting equipment or services
for monitoring airborne ethylene
oxide at an EO sterilization
facility
Annex K (Informative) - Bibliography and cited references
Gives guidelines for EO sterilization processing in hospitals and other health care facilities.
| DevelopmentNote |
Supersedes AAMI ST43. (08/2000) Supersedes AAMI TIR 1 (07/2002)
|
| DocumentType |
Standard
|
| Pages |
185
|
| ProductNote |
NEW CHILD ERR 1 IS NOW ADDED
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ASTM F 2038 : 2000 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| CSA Z314.1 : 2009 : R2013 | ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES |
| 11/30252448 DC : 0 | BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| PREN 14180 : DRAFT 2012 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| DD CEN ISO/TS 11135-2:2008 | Sterilization of health care products. Ethylene oxide Guidance on the application of ISO 11135-1 |
| AAMI TIR55 : 2014 | HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES |
| DIN EN ISO 11135:2014-10 | 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) |
| ASTM F 2042 : 2000 : R2005 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| CSA Z11135-2 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ST40 : 2004 : R2010 | TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ASTM F 2038 : 2000 : EDT 1 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ST24 : 1999 : R2013 | AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
| DIN EN 1422:2014-08 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN EN 1422:1997-11 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| 12/30262894 DC : 0 | BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| 11/30244091 DC : 0 | BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI TIR67 : 2018 | PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES |
| ASTM F 2042 : 2000 : EDT 1 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| AAMI ST24 : 1999 : R2005 | AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| I.S. EN 1422:2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| ANSI/AAMI ST90:2017 | PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
| UNE-EN ISO 11135:2015 | 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) |
| AAMI TIR63 : 2014 | MANAGEMENT OF LOANED CRITICAL AND SEMI-CRITICAL MEDICAL DEVICES THAT REQUIRE STERILIZATION OR HIGH-LEVEL DISINFECTION |
| AAMI TIR 11 : 2005 | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
| CSA Z314.9 : 2009 | INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES |
| AAMI ST50 : 2004 : R2010 | DRY HEAT (HEATED AIR) STERILIZERS |
| 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 |
| UNI CEN ISO/TS 11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| AAMI ST65 : 2008 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ST24:1999(R2018) | AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
| ASTM F 2042 : 2000 : R2011 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
| UNI EN 1422 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| AAMI ST91 : 2015 | FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
| ASTM F 2042 : 2000 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| AAMI TIR56 : 2013 | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| AAMI ST50 : 2004 | DRY HEAT (HEATED AIR) STERILIZERS |
| CSA Z314.1:2009 | ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES |
| CSA Z11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| BS EN 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 |
| CSA Z314.9 : 2009 : R2013 | INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES |
| ASTM F 2038 : 2000 : R2005 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| S.R. CEN ISO TS 11135-2:2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| UNI EN 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 |
| CSA Z314.2 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
| ASTM F 2038 : 2000 : R2011 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials |
| AAMI TIR11:2005(R2015) | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| PREN ISO 11135 : DRAFT 2011 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011) |
| AAMI ST65 : 2008 : R2013 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ST24 : 1999 : R2009 | AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| CSA Z11135-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| AAMI ST40 : 2004 | TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| EN 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) |
| I.S. EN 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) |
| AAMI ISO TIR 11135-2 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 |
| 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 |
| BS EN 1422:2014 | Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| CFR 29(PTS1900-1910) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| CFR 40(PT63) : JUL 98 | NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES |
| CFR 29(PTS1911-1925) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| AAMI ISO 15882 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| CFR 29(PTS1920-END) : 1986 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| CFR 49(PTS100-177) : OCT 2017 | TRANSPORTATION |
| ANSI/AAMI/ISO 11138-2:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
| AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ST24:1999(R2018) | AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
| NFPA 70 : 2017 | NATIONAL ELECTRICAL CODE |
| CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| ANSI Z358.1 : 2014 | EMERGENCY EYEWASH AND SHOWER EQUIPMENT |
| NFPA 30 : 2018 | FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE |
| CFR 49(PTS178-199) : OCT 2017 | TRANSPORTATION |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| ANSI/AAMI PB70:2012 | LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.