Skip to content
Please enter a keyword to search

  • ISO 11140-5:2007

    Current The latest, up-to-date edition.

    Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

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

    Language(s):  English, French

    Published date:  15-03-2007

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    ISO 11140-5:2007 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

    Additionally, ISO 11140-5:2007 includes test methods and equipment used to meet these performance requirements.

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

    Development Note Supersedes ISO/DIS 11140-5. (03/2007)
    Document Type Standard
    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
    PLUS 1173 (1st ed. pub. 2012) Guide to the selection and use of sterilization indicators
    PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat 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)
    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)
    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 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 Z314.3 : 2009 : R2014 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    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
    EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
    DIN EN ISO 11140-1:2015-03 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 General requirements
    BS EN ISO 14534:2015 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
    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)
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    12/30238553 DC : 0 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    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
    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
    AAMI ISO 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI/ISO TIR17665-3:2014(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
    BS EN ISO 18472:2006 Sterilization of health care products. Biological and chemical indicators. Test equipment and methods
    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)
    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
    ANSI/AAMI/ISO 20857:2010(R2015) STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    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
    16/30330536 DC : 0 BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    CSA Z314.3 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    CAN/CSA-Z314-18 Canadian medical device reprocessing
    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)
    ANSI/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
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    DIN EN ISO 20857 E : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    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)
    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
    UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    07/30164697 DC : 0 ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    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)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    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 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    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
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
    EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    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)
    BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
    BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
    DIN EN ISO 18472:2006-10 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    CSA Z15882 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
    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
    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
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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 (ISO/TS 17665-2:2009)

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

    ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    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
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    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
    View more information

    • 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, flexibile and cost effective