GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes (English)
GB/T 18281.2-2024 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
1 Scope
This document specifies requirements for test microorganisms, 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℃ to 65℃.
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.
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 18281.1-2024 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017, IDT)
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11138-1 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/.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test microorganism
5.1 The test microorganisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this document.
Note 1: Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.
Note 2: Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4418 and CIP 77.18 have been found to be suitable [1) Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4418 and CIP 77.18 are examples of suitable products available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement of these products.]1).
5.2 If a test microorganism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined.
6 Suspension
The requirements of ISO 11138-1 apply.
7 Carrier and primary package
7.1 The suitability of the Carrier and primary package materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of GB/T 18281.1-2024, 5.2 and Annex B.
7.2 The exposure conditions to determine compliance shall be:
a) minimum exposure temperature: greater than or equal to 55℃;
b) sterilizing agent: ethylene oxide gas at a concentration not less than 800mg/L in air at greater than or equal to 70% RH;
c) maximum exposure temperature: as stated by the biological indicator manufacturer; and
d) exposure time: greater than or equal to 6h.
Note: These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of an ethylene oxide sterilization process.
8 Inoculated carriers and biological indicators
The requirements of ISO 11138-1 apply.
9 Population and resistance
9.1 The manufacturer shall state the resistance characteristics of biological indicator in accordance with GB/T 18281.1-2024, 6.4.
9.2 The viable count per unit of biological indicator shall be stated as an integer multiple of an increment less than or equal to 0.1×10n per unit (e.g. per mL of suspension, per inoculated carrier or per biological indicator).
9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1.0×106.
9.4 The resistance shall be expressed as the D value in minutes, at 54℃. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated as the D value in minutes, to one decimal place at 54℃.
9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2.5min at 54℃ when tested according to the conditions in Annex A using test gas mixtures (see Annex B). Other microorganisms shall have D values supporting the application.
9.6 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2.0min at 54℃ when tested according to the conditions in Annex A using a test gas consisting of 100% ethylene oxide (see Annex B). Other microorganisms shall have D values supporting the application.
9.7 The resistance characteristics specified in this document and any other parts of ISO 11138 shall be defined using the specific critical variables associated with the referenced sterilization process.
9.8 D values are determined according to methods given in GB/T 18281.1-2024, Annex C and Annex D.
9.9 Determination of D value and survival-kill response characteristics require the use of a resistometer applying the reference resistometer process parameters (see Annex A).
9.10 The survival-kill window can be calculated using the formulae in GB/T 18281.1-2024, Annex E.
Contents
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test microorganism
6 Suspension
7 Carrier and primary package
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (Normative) Method for determination of resistance to ethylene oxide sterilization
Annex B (Informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30℃
Bibliography
GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes (English)
Standard No.
GB/T 18281.2-2024
Status
valid
Language
English
File Format
PDF
Word Count
7000 words
Translation Price(USD)
210.0
Implemented on
2025-12-1
Delivery
via email in 1 business day
Detail of GB/T 18281.2-2024
Standard No.
GB/T 18281.2-2024
English Name
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
GB/T 18281.2-2024 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
1 Scope
This document specifies requirements for test microorganisms, 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℃ to 65℃.
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.
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 18281.1-2024 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017, IDT)
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11138-1 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/.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test microorganism
5.1 The test microorganisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this document.
Note 1: Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.
Note 2: Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4418 and CIP 77.18 have been found to be suitable [1) Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4418 and CIP 77.18 are examples of suitable products available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement of these products.]1).
5.2 If a test microorganism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined.
6 Suspension
The requirements of ISO 11138-1 apply.
7 Carrier and primary package
7.1 The suitability of the Carrier and primary package materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of GB/T 18281.1-2024, 5.2 and Annex B.
7.2 The exposure conditions to determine compliance shall be:
a) minimum exposure temperature: greater than or equal to 55℃;
b) sterilizing agent: ethylene oxide gas at a concentration not less than 800mg/L in air at greater than or equal to 70% RH;
c) maximum exposure temperature: as stated by the biological indicator manufacturer; and
d) exposure time: greater than or equal to 6h.
Note: These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of an ethylene oxide sterilization process.
8 Inoculated carriers and biological indicators
The requirements of ISO 11138-1 apply.
9 Population and resistance
9.1 The manufacturer shall state the resistance characteristics of biological indicator in accordance with GB/T 18281.1-2024, 6.4.
9.2 The viable count per unit of biological indicator shall be stated as an integer multiple of an increment less than or equal to 0.1×10n per unit (e.g. per mL of suspension, per inoculated carrier or per biological indicator).
9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1.0×106.
9.4 The resistance shall be expressed as the D value in minutes, at 54℃. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated as the D value in minutes, to one decimal place at 54℃.
9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2.5min at 54℃ when tested according to the conditions in Annex A using test gas mixtures (see Annex B). Other microorganisms shall have D values supporting the application.
9.6 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2.0min at 54℃ when tested according to the conditions in Annex A using a test gas consisting of 100% ethylene oxide (see Annex B). Other microorganisms shall have D values supporting the application.
9.7 The resistance characteristics specified in this document and any other parts of ISO 11138 shall be defined using the specific critical variables associated with the referenced sterilization process.
9.8 D values are determined according to methods given in GB/T 18281.1-2024, Annex C and Annex D.
9.9 Determination of D value and survival-kill response characteristics require the use of a resistometer applying the reference resistometer process parameters (see Annex A).
9.10 The survival-kill window can be calculated using the formulae in GB/T 18281.1-2024, Annex E.
Contents of GB/T 18281.2-2024
Contents
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test microorganism
6 Suspension
7 Carrier and primary package
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (Normative) Method for determination of resistance to ethylene oxide sterilization
Annex B (Informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30℃
Bibliography
