This part of ISO 11140 specifies general requirements and test methods for indicators that reveal their exposure to sterilization processes through physical and/or chemical changes in substances and that are used to determine the achievement of one or more process parameters for a sterilization process are (is) to be monitored. Their effect is independent of the presence or absence of a living organism. NOTE 1 Biological test systems are those that depend on evidence of the viability of an organism for their evaluation. Test systems of this type are covered in the ISO 11138 series of standards for biological indicators (BI). The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to a subsequent part; in this case the requirement of this particular part applies. The corresponding testing devices are described in ISO 18472. NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.
EN ISO 11140-1:2014 Referenced Document
EN 13060:2004 Small steam sterilizers Incorporates Amendment A2: 2010
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
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 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
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 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 9001:2008 Quality management systems - Requirements
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17050-1:2004 Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
EN ISO 11140-1:2014 history
2014EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
2009EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements
2005EN ISO 11140-1:2005 Sterilization of health care products Chemical indicators Part 1: General requirements ISO 11140-1:2005