This standard specifies the specific requirements for test microorganisms and biological indicators to be used in the evaluation of the performance of sterilizers, which use pure ethylene oxide gas or its mixture with other diluent gases for sterilization, and the sterilization temperature range is 20℃～65℃. GB 18281.2-2000 Biological indicators for sterilization of health care products Part 2: Biological indicators for ethylene oxide sterilization GB18281.2-2000 Standard download decompression password: www.bzxz.net

GB 18281.2--2000
All technical contents of this standard are mandatory. Foreword
This standard is equivalent to the international standard ISO 11138-2:1994 "Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization"
Appendix A of this standard is a recommended appendix.
This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Sterilization Technology and Equipment [This standard is proposed by: Hangzhou Dianda Sterilization Equipment Factory, State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Shandong Xinhua Medical Device Co., Ltd. The main drafters of this standard: Zhou Qingqing, Chen Jiaye, Mo Fucheng, Yang Zhaoxu, Li Weisong GB18281.2-2000
ISO Foreword
ISO (International Organization for Standardization) is a global federation composed of national standardization bodies (ISO member bodies). The work of developing international standards is usually done by ISO's technical committees. If each member group is interested in a standard project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISO can also participate in related work. In the promotion of electrotechnical technical standards, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard formally adopted by the technical committee is submitted to the member groups for voting. The international standard must be approved by at least 75% of the member groups participating in the vote before it can be officially released. International standard ISO11138-2 was developed by ISO/TC198 Technical Committee on Sterilization of healthcare products. ISO11138 includes the following aspects: Sterilization of healthcare products - Biological indicators The following parts under the general title of indicators\: - Part 1: General
Part 2: Biological indicators for ethylene oxide sterilization Part 3 Biological indicators for moist heat sterilization
Appendix A is an integral part of this part of ISO11138. GB18281.2—2000
Standard GB18281.1 ISO11138-1 specifies the general requirements for the production, labeling and performance of biological indicators intended for sterilization cycle monitoring. This standard specifies the specific requirements for ethylene oxide sterilization cycles. It should be carried out by trained and suitable personnel.
Biological indicators are not intended for use in any process not specified by the manufacturer on the label. Improper use of biological indicators can produce misleading results.
Biological indicators should always be used in conjunction with physical and/or chemical monitoring to demonstrate the efficacy of the sterilization process. Regardless of the results obtained with the biological indicator, if a physical/chemical variable of the sterilization process exceeds the specified range, the sterilization cycle should be considered to have failed to meet the expected standards.
The performance of biological indicators can be affected by the storage environment before use, the method of use, or exposure to The influence of the technology used after the sterilization process, therefore, storage and use should be carried out in accordance with the manufacturer's recommendations. On the other hand, the biological indicator should be transferred to the specified resuscitation conditions as soon as possible after exposure to the sterilization process. If the biological indicator exceeds the expiration date specified by the manufacturer, it should not be used. Biological indicators are used to verify the effectiveness of sterilization processes and sterilization equipment. Such studies should be conducted by trained and appropriate personnel. National Standard of the People's Republic of China
Biological Indicators for Sterilization of Health Care Products
Part 2: Sterilization of Biological Indicators for Ethylene Oxide Sterilization of health care products-- Biological indicators-Part 2: Biological indicators for ethylchc oxlde sterilizatlon1Scope
GB 18281. 2-2000
idt ISO 11138-2: 1994
This standard specifies the special requirements for test microorganisms and biological indicators to be used in evaluating the performance of sterilizers, which use pure ethylene oxide gas or its mixture with other diluent gases for sterilization, and the sterilization temperature range is 20℃～65℃. 2 Reference standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB18281.1-2000 Biological indicators for sterilization of medical products Part 1: General (idtISO11138-1:1994) 3 Definitions
This standard adopts the definitions listed in CB18281.1-1SO11138-1. 4 General
Except for the following clauses of this standard which are modified, the requirements of GB18281.1-1SO11138-1 apply. 5 Test microorganisms
The test microorganism must be spores of Bacillus subtilis or other strains or microorganisms that have been proven to have equivalent performance as required by this standard.
Note 1: It has been confirmed that Bacillus subtilts NCTC.10973, C1P7718. and D, subtls ATCC9372 are suitable strains. 6 Microbial suspension
The number of live test microorganisms contained in the same batch of bacterial suspension must be within the rated number range ±35%. 7 Carrier and inner packaging
For special requirements for carriers and inner packaging, see GB18281.1-1SO11138-14.4. The test conditions used to confirm the qualification of carrier and inner packaging materials should be: temperature: not less than 55℃;
Relative humidity: not less than 70%
-Gas liquid concentration: not less than 800mg/1;
Approved by the State Administration of Quality and Technical Supervision on December 13, 2000 and implemented on May 1, 2001
-Decomposition time is not less than 6h.
GB 1828122000
Note 2: As long as the carrier is still within the practical range of the ethylene oxide sterilization process, these selected conditions represent the actual inspection of the carrier. 8 Biological indicators
8.1 During the production process, the number of resuscitable test microorganisms on each biological indicator must be controlled to be limited to within 50% of the rated total number specified by the manufacturer, or within the minimum and maximum values ​​of the total number specified by the manufacturer. 8.2 The test microorganisms are separated from the carrier by ultrasound, shaking with glass balls or other approved appropriate physical methods, and the bacterial suspension of the test microorganisms obtained must be cultured under the culture conditions specified by the manufacturer. The number is traceably determined by counting viable bacteria. If the number obtained is within the range of -50% and +300% of the rated total number specified by the manufacturer, or between the minimum and maximum values ​​of the total number specified by the manufacturer, it should be judged as qualified. 8.3 The total nominal number of test microorganisms for inoculum carriers and biological indicators intended for use in routine monitoring must be not less than 1 x 10, with specified increments not exceeding 0.1 x 10.
Note 3: For inoculum carriers and/or biological indicators used in other areas such as qualification, confirmation or other specific tests, another total nominal number may be required. 9 Resistance
9.1 The manufacturer must mark the D value for each batch of biological indicators or inoculum carriers with an accuracy of 0.5 min. 9.2 The resistance characteristics of each batch of biological indicators must be determined in accordance with the provisions of Appendix A. 9.3 The D value of the total number of test microorganisms on the biological indicator can be obtained by the survival curve method and/or the partial positive analysis method using the most probable number (MPN) step (see Appendix B and Appendix C of GB18281.1-ISO11138-1 respectively). If exposed to 600 mg/l.±30 mg/l. ethylene oxide, relative humidity is 60%+10%, and temperature is 30℃±1℃, the time must be not less than 12.5 minutes; or if the temperature is controlled at 54℃1℃ and the other test conditions are the same, the time is 2.5 minutes. 10 Test method Www.bzxZ.net
The test method given in this standard is the reference method. If other alternative methods are required, they must be specified and confirmed and confirmed to be consistent with this basic method.
GB18281.2—2000
Appendix A
(Standard Appendix)
Method for determining resistance to ethylene oxide sterilization A1 Cyclohexane biological indicator resistance tester A1.1 The tester must be capable of maintaining the conditions listed in Table A1 within the specified range, with an exposure time range of 1 min to 12 min and an accuracy of ± 10 s. In addition, the equipment must be capable of maintaining an exposure time greater than 6 h. Table A1 Conditions for Biological Indicator Resistance Studies
Ethylene Oxide
Relative Humidity
60 Gmg/L=30 mg/L
a0c±i or 4°C±1°C
60%+10%
A1.2 The tester must be equipped with a vacuum pump to allow the reaction chamber to be vacuumed to less than 10 kPa (100 mbar) so that the room air can be fully removed before the sterilant is introduced and the sterilant is exhausted at the end of the exposure period. The air introduced at the end of the cycle must be filtered through a filter that can remove not less than 99.9% of 0.5 mm particles. 41.3 The time required from the start of the sterilizing gas flow to the specified gas concentration must not exceed 60 s; furthermore, the time required to remove the sterilizing gas and bring the pressure to 10 kPa (100 mbar) at the end of the exposure period must not exceed 60 s. A1.4 The reaction chamber and door must be equipped with means to maintain the internal surface temperature at the required operating temperature. A1.5 The ethylene oxide gas supplied to the reaction chamber must be filtered and preheated to ensure that neither liquid ethylene oxide nor polymer particles are introduced into the chamber.
A1.6 The measuring instrument must be capable of automatic operation and shall be equipped with a device that is independent of the control function to record the temperature, pressure, and humidity in the chamber. In addition, the error range of the recording device shall not exceed 50% of the tolerance for each controlled variable. For example, if the room temperature is required to be controlled within ±1 K, the maximum tolerance limit of the temperature recorder is 20.5 K. A2 Operation of the measuring instrument
A2.1 Place the carrier, inoculum, or biological indicator on a suitable sample carrier. A2.2 Ensure that the measuring chamber is preheated to the required temperature (30°C ± 1°C or 54°C ± 1°C). 42.3 Place the sample loading device in the chamber, close the reaction chamber, and maintain the specified period of time to allow the temperature to stabilize. A2.4 The automatic control operation must be carried out in the following order: a) Evacuate the reaction chamber to 10 kPa ± 0.4 kPa 100 mbar ± 4 mbar); h) Pass sufficient water vapor to make the relative humidity in the chamber reach 60% ± 10%. Maintain this condition for 28min to 30min; c) Pass ethylene oxide into the chamber: within 60s, the concentration reaches 600mg/L ± 30mg/L; Note 4: When the exposure time is 0min, ethylene oxide should be passed. dl) Maintain the conditions in c) for the specified exposure time; e) At the end of the exposure phase, evacuate the reaction chamber to a pressure of 10 kPa ± 0.4 kPa (100 mbar ± 4 mbar) within 60 s, then allow filtered air or an inert gas (e.g. nitrogen) to be introduced to the ambient pressure; f) Repeat step e) for another four times.
42.5 At the end of this cycle, remove the sample carrier and sample from the reaction chamber. A3 Determination of resistance
Determine the resistance in accordance with the method specified in Chapter 5 (and related appendices) of CB18281. [—IS () 11138.1).
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