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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS

Available format(s): Hardcopy, PDF

Superseded date: 25-01-2020

Language(s):

Published date: 01-01-2008

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

Gives guidelines for EO sterilization processing in hospitals and other health care facilities.

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes AAMI ST43. (08/2000) Supersedes AAMI TIR 1 (07/2002)
Document Type	Standard
ISBN
Pages
Product Note	NEW CHILD ERR 1 IS NOW ADDED
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	ANSI/AAMI ST41:2008(R2018)
Supersedes	AAMI TIR 1 : LATEST AAMI ST43 : 3ED 93

Standards Referenced By This Book - (Show below) - (Hide below)

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
CEN ISO/TS 11135-2:2008/AC:2009	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
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

Standards Referencing This Book - (Show below) - (Hide below)

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

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