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  • AAMI ST41 : 2008

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  25-01-2020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

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    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
    Product Note NEW CHILD ERR 1 IS NOW ADDED
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    PREN 1422 : DRAFT 2011 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 TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
    12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    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
    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 ST90 : 2017 PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    AAMI ST58 : 2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    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
    PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    AAMI ST50 : 2004 DRY HEAT (HEATED AIR) STERILIZERS
    CSA Z314.1:2009 ETHYLENE OXIDE STERILIZERS FOR 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
    DD CEN ISO/TS 11135-2 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 (ISO/TS 11135-2:2008)
    AAMI TIR55 : 2014 HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES
    AAMI TIR 11 : 2005 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
    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
    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
    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
    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)
    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
    AAMI TIR67 : 2018 PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES
    AAMI ST40 : 2004 : R2010 TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    CSA Z314.9 : 2009 : R2013 INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS 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
    ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    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 TIR56 : 2013 : R2016 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
    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 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
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    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
    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
    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
    ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    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
    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
    DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    BS EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    AAMI TIR 11 : 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
    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
    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
    EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS

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

    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
    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
    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
    AAMI PB70 : 2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
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