GB 18281.2-2015 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 strains of microorganisms of demonstrated equivalent performance as required by this standard.
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.
5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined.
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
医疗保健产品灭菌 生物指示物
第2部分：环氧乙烷灭菌用生物指示物
1 范围
GB 18281的本部分规定了拟在评价灭菌器性能和灭菌过程时采用的试验微生物、菌悬液、染菌载体、生物指示物的专用要求和试验方法，该灭菌器使用纯环氧乙烷或它与其他稀释气体混合进行灭菌，灭菌温度范围为29℃～65℃。
注1：关于环氧乙烷灭菌确认与常规控制见GB 18279。
注2：工作场所的安全参照国家的相关规定。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。
ISO 11138-1：2006 医疗保健品灭菌 生物指示物 第1部分：通则(Sterilization of health care products—Biological indicators—Part 1： General requirements)
ISO 18472 医疗保健产品的灭菌 生物与化学指示物 测试设备(Sterilization of health care products—Biological and chemical indicators—Test equipment)
3 术语和定义
ISO 11138-1界定的术语和定义适用于本文件。
4 通则
ISO 11138-1的要求适用于本部分。
5 试验微生物
5.1 试验微生物应为萎缩芽孢杆菌芽孢、枯草芽孢杆菌芽孢或其他符合本部分要求的菌株。
注1：原枯草芽孢杆菌中的一些菌株已被重新归类为萎缩芽孢杆菌。
注2：据证实，萎缩芽孢杆菌ATCC 9372、NCTC 10073、NCIMB 8058、DSM 2277、NRRL B-4418和CIP 77.18是合适的菌株。
5.2 如果试验微生物不是萎缩芽孢杆菌，应确定此试验微生物抗力的适宜性。
6 菌悬液
ISO 11138-1的要求适用于本部分。
