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  • ISO 11138-2:2017

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    Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  03-03-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 C to 65 C.

    NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

    NOTE 2 National or regional regulations can provide requirements for work place safety.

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

    Committee ISO/TC 198
    Development Note Supersedes ISO/DIS 11138-2. (03/2017)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    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
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
    04/30048118 DC : DRAFT MAY 2004 BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS ISO 17218 : 2014 STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    17/30363625 DC : DRAFT SEP 2017 BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    PLUS 1173 (1st ed. pub. 2012) Guide to the selection and use of sterilization indicators
    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 ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
    04/30090382 DC : DRAFT NOV 2004 ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
    08/30149503 DC : DRAFT JAN 2008 BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    16/30330536 DC : 0 BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    VDI 6300-1 : 2016 GENETIC ENGINEERING OPERATIONS IN GENETIC ENGINEERING FACILITIES - GUIDANCE ON SAFE OPERATION OF GENETIC ENGINEERING FACILITIES
    I.S. EN ISO 11135-1:2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    04/30078095 DC : DRAFT JUL 2004 ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    AAMI TIR20 : 2001 PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
    13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    ISO 18746:2016 Traditional Chinese medicine Sterile intradermal acupuncture needles for single use
    CSA Z15882 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    BS EN 60601-2-12 : 2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    DIN EN ISO 18472:2006-10 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    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
    04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    CSA Z14161 : 2011 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    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)
    16/30302485 DC : 0 BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    NF CEN ISO/TS 11135-2 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    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)
    03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    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
    EN ISO 11135:2014 (edition 2) 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)
    07/30157769 DC : DRAFT DEC 2007 BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
    CSA Z1416: 2011 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    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
    CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
    CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    CSA Z11135-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    CSA Z15882:09 (R2019) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 11737-1:2009-09 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
    CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    ISO 11737-1:2018 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products
    AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
    I.S. EN ISO 11737-1:2018&LC:2018 STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
    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)
    UNI CEN ISO/TS 11135-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    BS EN ISO 18472:2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    EN ISO 18472 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    AAMI ISO 11737-2 :2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    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
    UNI EN ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
    AAMI ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11737-1 : 2006 : R2011 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
    AAMI ISO 18472 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    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
    ONORM EN ISO 18472 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    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 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 ISO 11140-1 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 17218:2014 Sterile acupuncture needles for single use
    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
    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
    I.S. EN ISO 18472:2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    DIN EN ISO 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
    BS EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    BS EN ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO 15882:2008 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    BS EN ISO 11737-2:2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    BS EN ISO 11140-1 : 2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    UNE-EN ISO 14161:2010 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
    BS EN ISO 14534:2015 (published 2015-02) Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    BS EN ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    ANSI/AAMI/ISO 15882:2008(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    EN ISO 11737-2 : 2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    BS EN ISO 15882:2008 (published 2009-01) Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
    I.S. EN ISO 14161:2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    I.S. EN ISO 11737-2:2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    EN ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    I.S. EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
    I.S. EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    UNI EN ISO 11737-2 : 2010 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    I.S. EN ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    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
    DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
    EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    EN 60601-2-12 : 2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    EN ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    EN ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS (ISO 15882:2008)

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

    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11138-1:2017 Sterilization of health care products Biological indicators Part 1: General requirements
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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