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
醫療保健產品滅菌 生物指示物
第2部分：環氧乙烷滅菌用生物指示物
1 范圍
GB 18281的本部分規定了擬在評價滅菌器性能和滅菌過程時采用的試驗微生物、菌懸液、染菌載體、生物指示物的專用要求和試驗方法，該滅菌器使用純環氧乙烷或它與其他稀釋氣體混合進行滅菌，滅菌溫度范圍為29℃～65℃。
注1：關于環氧乙烷滅菌確認與常規控制見GB 18279。
注2：工作場所的安全參照國家的相關規定。
2 規范性引用文件
下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。
ISO 11138-1：2006 醫療保健品滅菌 生物指示物 第1部分：通則(Sterilization of health care products—Biological indicators—Part 1： General requirements)
ISO 18472 醫療保健產品的滅菌 生物與化學指示物 測試設備(Sterilization of health care products—Biological and chemical indicators—Test equipment)
3 術語和定義
ISO 11138-1界定的術語和定義適用于本文件。
4 通則
ISO 11138-1的要求適用于本部分。
5 試驗微生物
5.1 試驗微生物應為萎縮芽孢桿菌芽孢、枯草芽孢桿菌芽孢或其他符合本部分要求的菌株。
注1：原枯草芽孢桿菌中的一些菌株已被重新歸類為萎縮芽孢桿菌。
注2：據證實，萎縮芽孢桿菌ATCC 9372、NCTC 10073、NCIMB 8058、DSM 2277、NRRL B-4418和CIP 77.18是合適的菌株。
5.2 如果試驗微生物不是萎縮芽孢桿菌，應確定此試驗微生物抗力的適宜性。
6 菌懸液
ISO 11138-1的要求適用于本部分。
