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  • ISO 11140-3:2007

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    Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

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

    Language(s): 

    Published date:  15-03-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.

    Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

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

    Committee ISO/TC 198
    Development Note Supersedes ISO/DIS 11140-3. (03/2007)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO EN 867-3
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    CSA Z15882 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    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)
    PLUS 1173 (1st ed. pub. 2012) Guide to the selection and use of sterilization indicators
    I.S. EN ISO 17665-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    16/30330536 DC : 0 BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    I.S. EN 11140-4:2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
    BS PD ISO/TS 17665-3 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    PREN ISO 11140-1 : DRAFT 2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
    DIN EN ISO 18472:2006-10 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
    CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    DD CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    12/30238553 DC : 0 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    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)
    S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    05/30138310 DC : DRAFT AUG 2005 ISO 15882 ED 2 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    AAMI ISO 11140-4 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
    AAMI ISO 17665-1 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    NBR ISO 17665-1 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11140-4 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
    AAMI ISO TIR 17665-3 : 2014 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    AAMI ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
    CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
    AAMI ISO TIR 17665-2 : 2009 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    AAMI ISO 17665-1 : 2006 : R2013 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    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
    CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO/TS 17665-3:2013 Sterilization of health care products Moist heat Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    AAMI ISO 18472 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    CSA ISO 11140-1 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    BS EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    I.S. EN ISO 18472:2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN ISO 11140-4:2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    ISO 15882:2008 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results
    BS EN ISO 11140-4:2007 Sterilization of health care products. Chemical indicators Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    BS EN ISO 11140-1 : 2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    BS EN ISO 14534:2015 (published 2015-02) Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
    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
    BS EN ISO 17665-1:2006 (published 2006-09) Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 11140-4:2007 Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    BS EN 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    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 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 ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    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)
    CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    EN ISO 11140-4 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
    EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    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)

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    ISO 15882:2008 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    ISO 187:1990 Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
    ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets
    ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
    ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
    ISO 9001:2015 Quality management systems Requirements
    ISO/CIE 10526:1999 CIE standard illuminants for colorimetry
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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