This standard specifies the specific requirements for test microbial indicators to be used in evaluating the performance of sterilizers that use moist heat at a sterilization temperature exceeding 100°C as a sterilization factor. GB 18281.3-2000 Biological indicators for sterilization of health care products Part 3: Biological indicators for moist heat sterilization GB18281.3-2000 Standard download decompression password: www.bzxz.net

GB18281.3—2000
All technical contents of this standard are mandatory. The standard is equivalent to the international standard ISO11138-3:1995 "Biological indicators for heat sterilization of medical and health products".
Appendix A and Appendix B of this standard are both standard appendices. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Sterilization Technology and Equipment Standardization Technical Committee. Biological indicators
Part 3:
This standard was drafted by Dongxinhua Medical Device Co., Ltd. and the State Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
Main drafters of this standard: Yang Zhaoxu, Liang, Mo Fucheng62.
GB 18281.3-2000
ISO Foreword
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ISO (International Organization for Standardization) is a worldwide federation of national standardization bodies (ISO member groups). The work of formulating international standards is usually completed by ISO's technical committees. If each member group is interested in a standard item 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 may also participate in the relevant work. In all aspects of electrotechnical standardization, 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 can only be officially released after obtaining the consent of at least 75 of the member groups participating in the voting. International Standard 1S0) 11138-3 was developed by ISO/TC198 Technical Committee Sterilization of healthcare products.
ISO) 11138 includes the following parts under the general heading of \Sterilization of healthcare products Part 1: General
Part 2: Biological indicators for ethane sterilization Part 3: Biological indicators for heat sterilization
Biological indicators\: Annex A and Annex B are the organic components of this part of ISO11138, 62.3
GB18281.3-2000
This standard specifies the general requirements for the production, labeling and performance of biological indicators intended for wet heat sterilization period testing. The specified steps and methods should be implemented by trained and suitable personnel. Biological indicators are not intended for use in any process not specified on the label. Improper use of biological indicators may produce misleading results.
Biological indicators should always be used in conjunction with physical and/or chemical tests 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 achieve the intended goal.
The performance of biological indicators can be affected by the storage environment before use, the method of use, or the technology used after exposure to the sterilization process. Therefore, storage and use should be carried out in accordance with the manufacturer's recommendations. However, biological indicators should be transferred to the specified resuscitation conditions as soon as possible after exposure to the sterilization process. Biological indicators should not be used if they have exceeded the expiration date specified by the manufacturer. Biological indicators are used to verify the effectiveness of sterilization processes and sterilization equipment. Such analytical studies should be performed by trained and appropriate personnel. 626
National Standard of the People's Republic of China
Sterilization of healthcare products
Biological indicators,
Part 3: Biological indicators for moist heat sterilizationScope
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GB18281.3---2000
idtIso11138-3:1995
This standard specifies the specific requirements for test microorganisms and biological indicators to be used in the evaluation of the performance of sterilizers using moist heat at a sterilization temperature exceeding 100°C as the ignition factor. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, the editions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest edition of the following standards. GB18278-2000 Requirements for confirmation and routine control of bacteria in health care products Industrial moist heat sterilization (1dtIS011134:1994)
GB18281.1-2000 Biological indicators for sterilization of health care products Part 1: General (idt1S011138-1:1994) 3 Definitions
This standard adopts the definitions of GB18281.1ISO11138-1 and the following definitions. 3.1 2 Value-value
The temperature required to change the D value by one order of magnitude. 4 General
Except for the following clauses of this standard as modified contents, the requirements of GB18281.1ISO111381 are applicable 5 Test microorganisms
The test microorganism must be spores of Bacillus stearathermophilus or other strains and microorganisms that have been proven to have equivalent performance as required by this standard. Jiang 1: It has been confirmed that the thermophilic fat-resistant bacteria (Bacilus stearothermophilus) NCTC100C3.DSM497, thermophilic fat-resistant rod (Js.stee-rothiur-mopailus) ATCC:12980.DSM 22 and thermophilic fat-resistant rod Xie (B. rearathermophilus CiP 52.81,SM 5332, ATCC7953, NCTC10007 are the most suitable strains. 6 Microbial suspension
Repeated determination of the number of viable test microorganisms contained in the same batch of suspension must be within the rated total number of 35. Approved by the State Administration of Quality and Technical Supervision on December 13, 2000 and implemented on May 1, 2001
7 Carriers and inner packaging
GB18281.3-2000
For special requirements for carriers and inner packaging, see (3B18281.1-1S0) 11138-1, 4.4 The test conditions that must be used to prove suitability are as follows: Temperature: not less than the "production" specified The maximum exposure temperature is +5°C. If not specified, the temperature must be 145°C. Exposure time: not less than the maximum exposure time specified by the manufacturer. If not specified, the exposure time must be 30 minutes. Note 2: As long as the carrier remains within the effectiveness range of the steam sterilization process, these selected conditions represent the actual test of the carrier. 8 Biological indicators || TT || 8.1 During the production process, the number of reproducible test microorganisms on each biological indicator must be controlled to be limited to the rated total range specified by the manufacturer - 505 - or within the minimum and maximum value of the total specified in the production. 8.2 Use ultrasound, oscillation with glass balls Physical methods or other approved appropriate methods are used to separate the test microorganisms from the carrier, and the suspension of the test microorganisms obtained must be cultured under the conditions specified by the manufacturer. The traceability of the number of microorganisms is determined by counting the number of live microorganisms. If the number of microorganisms obtained is within the range of 50% and 300% of the rated value, it should be judged as qualified. 8.3 The total number of test microorganisms for inoculation carriers and biological indicators intended for use in routine monitoring must be no less than 1×105, and the increase must be specified to be no more than 0.1×10.
If the biological indicator system that is equipped with the product meets the requirements of Article 9.3, when used for routine monitoring, the test microorganisms The rated total may be less than 1×10%
Note 3: Other aspects such as inoculation carriers and/or biological indicators used in qualification, confirmation or other specific tests may require another rated total: For some daily monitoring applications, a suspected total of 1×11% may be required. 9 Resistance
9.1 The manufacturer must indicate the D value of each batch of biological indicators or inoculation carriers with an accuracy of ±0.5min. 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 survival hill line method and/or the partial negative analysis method using the most probable number (MPN) step (see Chapter 5 and Appendix B of GB18281.1-ISO 11138-1, respectively,Appendix C, Appendix D) To obtain the D value of the total number of test microorganisms on the biological indicator, if exposed to humidity and heat at 121 °C, the time must be not less than 1.5 min. The T value of the logarithmic multiple of the total number must be not less than 10 min. 9.4 The D value of the test microorganisms on the inoculated carrier must be determined at two temperatures within the range of 110 °C to 130 °C using one of the two methods given. These data should be used to calculate the D value. The value must not be lower than 6 °C, and the increase must be specified not to be greater than 0.1. The Z value should be calculated according to Appendix B.
10 Test method
The test method given in this standard is the reference method. If other optional methods are used, they must be specified and confirmed and confirmed to be consistent with this reference method.
A1 Steam biological indicator resistance tester
GB 18281.32000
Appendix A
(Standard Appendix)
Method for determining resistance to moist heat sterilization
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A1.1 The tester must be able to maintain the following conditions within the given range, exposure time range 5 s~～180 min, accuracy ±1 s temperature: (110T~145)10.5T;
.-pressure: (140 kPa~-413 kPa)±2.5kPa; vacuum: (4 kPa～100 kPa)±0.5 kPa. or. When used for testing biological indicators, the pressure shall not be less than 10 kPa. Such indicators are intended for use in cycles including the exhaust phase.
A1.2 The measuring instrument must be equipped with a vacuum device to allow the vacuum degree of the reaction chamber to be reduced to less than 5 kPa within 5 minutes so that the indoor air can be fully removed before the steam is introduced. After the chamber is evacuated, steam flushing and (or) repeated alternating steam introduction methods must no longer be used to achieve exhaust. A1.3 At the end of the cycle, the air introduced must be filtered through a filter that can remove no less than 99.9% of 0.5m1 particles.
A1.4 The reaction chamber and door must be equipped with a device to keep the internal surface temperature of the chamber at the required working temperature. A1.5 The reaction chamber must be supplied with moist heat from outside the reaction chamber, and the steam source must comply with GB18281-ISO11134 standards. A1.6 The measuring instrument must be able to operate automatically and should be equipped with a device that can record the indoor temperature and pressure without being restricted by the control function. Therefore, the error range of the recording device must not exceed 50% of the tolerance of each controlled variable. For example, if the room temperature is required to be controlled within 10°C, the maximum tolerance limit of the temperature recorder is 0.5°C. 41.7 The heating time in the measuring chamber must not exceed 10. A1.8 At the end of the exposure period, the temperature in the measuring chamber must drop to 100°C or below 10°C in no more than 10 seconds, and the pressure in the chamber must return to the ambient pressure in less than 5 seconds. A2 Measurement Equipment Operation
A2.1 Place the carrier, inoculated carrier, or biological indicator on a suitable sample loading device. A2.2 Allow the measuring chamber to preheat to the required temperature. A2.3 Place the sample loading device in the chamber and close the reaction chamber for a specified period of time to allow the temperature to stabilize. A2.4 Automatically control the operation in the following order: a) The reaction chamber is evacuated to 4.5 kPa ± 0.5 kPa within 5 minutes (or to 10 kPa for the pressurized exhaust cycle); b) Steam is introduced into the chamber to reach the specified temperature and pressure; Note 4: When the exposure time is 0 minutes, no steam should be introduced. C) The system is maintained within the specified decomposition time: d) At the end of the exposure stage, the reaction chamber is evacuated to 10 kPa + 3.5 kPa, and then filtered air or some inert gas (such as nitrogen) is introduced to reach the external pressure within 5 minutes. A2.5 At the end of the cycle, remove the sample carrier and sample from the reaction chamber. A3 Determination of resistance
Determine the resistance according to the method specified in Chapter 5 (and related appendix) of GB 1828]. [---IS() 11138-1.32000
Appendix County
(Standard Appendix)
Calculation of z value
According to the method and data specified in Article 9.3, calculate the value expressed in degrees Celsius according to the following formula (T1-T1)
= (gD -IgD)
Where D. and: are the I) values ​​obtained at temperatures T1 and T1 respectively. : 630-T1)
= (gD -IgD)bzxZ.net
where D and : are the I) values ​​obtained at temperatures T1 and T2, respectively. ：630-T1)
= (gD -IgD)
where D and : are the I) values ​​obtained at temperatures T1 and T2, respectively. ：630
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