GB 18281.1-2015 Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
1 Scope
This part of GB 18281 provides specific requirements for test organisms, 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 GB 18279.
Note 2: National or regional regulations could provide requirements for work place safety.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment
3 Term and definition
For the purposes of this document, the terms and definitions given in ISO 11138-1 apply.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test organism
5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other
Foreword I Introduction III 1 Scope 2 Normative references 3 Term and definition 4 General requirements 5 Test organism 6 Suspension 7 Carrier and primary packaging 8 Inoculated carriers and biological indicators 9 Population and resistance Annex A (Normative) Method for determination of resistance to ethylene oxide sterilization Bibliography
GB 18281.1-2015 Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
1 Scope
This part of GB 18281 provides specific requirements for test organisms, 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 GB 18279.
Note 2: National or regional regulations could provide requirements for work place safety.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment
3 Term and definition
For the purposes of this document, the terms and definitions given in ISO 11138-1 apply.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test organism
5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other
Contents of GB 18281.1-2015
Foreword I
Introduction III
1 Scope
2 Normative references
3 Term and definition
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (Normative) Method for determination of resistance to ethylene oxide sterilization
Bibliography
