GB/T 18281.1-2024 Sterilization of health care products - Biological indicators - Part 1: General requirements
1 Scope
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and test suspensions, and their components, to be used in the validation and monitoring of sterilization processes.
This document specifies basic requirements that are applicable to all parts of GB/T 18281. Requirements for biological indicators for particular specified processes are provided in the relevant parts of GB/T 18281. For biological indicators for which no specific requirements are given, this document applies.
Note: National or regional regulations can apply.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1-2023 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018, IDT)
Note: There are no technical differences between the referenced content from GB/T 19973.1-2023 and that from ISO 11737-1:2016.
ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Note: GB 18279-2023 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, MOD)
ISO 11138-2 Sterilization of health care products - Biological and chemical indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
Note: GB/T 18281.2-2024 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017, IDT)
ISO 11138-3 Sterilization of health care products - Biological and chemical indicators - Part 3: Biological indicators for moist heat sterilization processes
Note: GB/T 18281.3-2024 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017, IDT)
ISO 11138-4 Sterilization of health care products - Biological and chemical indicators – Part 4: Biological indicators for dry heat sterilization processes
Note: GB/T 18281.4-2024 Sterilization of health care products - Biological indicators – Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017, IDT)
ISO 11138-5 Sterilization of health care products - Biological and chemical indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
Note: GB/T 18281.5-2024 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017, IDT)
ISO 11138-7 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
Note: GB/T 18281.7-2024 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019, IDT)
ISO 11138-8 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Note: GB/T 18281.8-2024 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021, IDT)
ISO 14937 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
Note: GB/T 19974-2018 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 14937:2009, IDT)
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Note: GB 18278.1-2015 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, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——IEC Electropedia: available at http://www.electropedia.org/;
——ISO Online browsing platform: available at http://www.iso.org/obp/.
3.1
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[Source: ISO 11139:2018, 3.29]
3.2
carrier
supporting material on or in which test microorganisms are deposited
3.3
colony forming unit; CFU
individual visible units of viable microorganisms arising from a single cell or multiple cells
3.4
culture collection number
unique identification of the test microorganism allocated by a scientifically recognized service culture collection
3.5
culture conditions
combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms
Note: The manner of incubation can include the temperature, time and any other conditions specified for incubation.
[Source: ISO 11139:2018, 3.70]
3.6
D value
D10 value
time or dose required to achieve inactivation of 90% of a population of the test microorganism under stated conditions
Note: Other critical process variable(s) exhibiting first order inactivation kinetics can achieve an inactivation of 90% of a population of the test microorganism under stated conditions.
[Source: ISO 11139:2018, 3.75, modified]
3.7
inactivation
loss of ability of microorganisms to grow and/or multiply
[Source: ISO/TS 11139:2006[ Withdrawn. This source is retained because this term is not included in the latest edition ISO 11139:2018.], 2.21]
3.8
inoculated carrier
supporting material on or in which a defined number of viable test microorganisms have been deposited
Note: See Annex F.
3.9
nominal population
manufacturer’s stated number of viable microorganisms on test samples
Note: This is generally expressed in log 10 function (e.g. 10⁶).
Contents
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (Normative) Determination of viable count
Annex B (Normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
Annex C (Normative) D value determination by survivor curve method
Annex D (Normative) D value determination by fraction negative method
Annex E (Normative) Survival-kill response characteristics
Annex F (Informative) Relationship between components of biological indicators
Bibliography
GB/T 18281.1-2024 Sterilization of health care products - Biological indicators - Part 1: General requirements
1 Scope
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and test suspensions, and their components, to be used in the validation and monitoring of sterilization processes.
This document specifies basic requirements that are applicable to all parts of GB/T 18281. Requirements for biological indicators for particular specified processes are provided in the relevant parts of GB/T 18281. For biological indicators for which no specific requirements are given, this document applies.
Note: National or regional regulations can apply.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1-2023 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018, IDT)
Note: There are no technical differences between the referenced content from GB/T 19973.1-2023 and that from ISO 11737-1:2016.
ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Note: GB 18279-2023 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, MOD)
ISO 11138-2 Sterilization of health care products - Biological and chemical indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
Note: GB/T 18281.2-2024 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017, IDT)
ISO 11138-3 Sterilization of health care products - Biological and chemical indicators - Part 3: Biological indicators for moist heat sterilization processes
Note: GB/T 18281.3-2024 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017, IDT)
ISO 11138-4 Sterilization of health care products - Biological and chemical indicators – Part 4: Biological indicators for dry heat sterilization processes
Note: GB/T 18281.4-2024 Sterilization of health care products - Biological indicators – Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017, IDT)
ISO 11138-5 Sterilization of health care products - Biological and chemical indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
Note: GB/T 18281.5-2024 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017, IDT)
ISO 11138-7 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
Note: GB/T 18281.7-2024 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019, IDT)
ISO 11138-8 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Note: GB/T 18281.8-2024 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021, IDT)
ISO 14937 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
Note: GB/T 19974-2018 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 14937:2009, IDT)
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Note: GB 18278.1-2015 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, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——IEC Electropedia: available at http://www.electropedia.org/;
——ISO Online browsing platform: available at http://www.iso.org/obp/.
3.1
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[Source: ISO 11139:2018, 3.29]
3.2
carrier
supporting material on or in which test microorganisms are deposited
3.3
colony forming unit; CFU
individual visible units of viable microorganisms arising from a single cell or multiple cells
3.4
culture collection number
unique identification of the test microorganism allocated by a scientifically recognized service culture collection
3.5
culture conditions
combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms
Note: The manner of incubation can include the temperature, time and any other conditions specified for incubation.
[Source: ISO 11139:2018, 3.70]
3.6
D value
D10 value
time or dose required to achieve inactivation of 90% of a population of the test microorganism under stated conditions
Note: Other critical process variable(s) exhibiting first order inactivation kinetics can achieve an inactivation of 90% of a population of the test microorganism under stated conditions.
[Source: ISO 11139:2018, 3.75, modified]
3.7
inactivation
loss of ability of microorganisms to grow and/or multiply
[Source: ISO/TS 11139:2006[ Withdrawn. This source is retained because this term is not included in the latest edition ISO 11139:2018.], 2.21]
3.8
inoculated carrier
supporting material on or in which a defined number of viable test microorganisms have been deposited
Note: See Annex F.
3.9
nominal population
manufacturer’s stated number of viable microorganisms on test samples
Note: This is generally expressed in log 10 function (e.g. 10⁶).
Contents of GB/T 18281.1-2024
Contents
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (Normative) Determination of viable count
Annex B (Normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
Annex C (Normative) D value determination by survivor curve method
Annex D (Normative) D value determination by fraction negative method
Annex E (Normative) Survival-kill response characteristics
Annex F (Informative) Relationship between components of biological indicators
Bibliography
