GB 18282.1-2000 Chemical indicators for sterilization of medical and health care products Part 1: General
Some standard content:
GB18282.1—2000
All technical contents of this standard are mandatory. Foreword
This standard is equivalent to the international standard ISO11140-1:1995 "Chemical indicators for fire and bacteria in medical and health products Part 1: General principles". The content of TS01J140-1:1995 Amendment 1 (1998-12-01) has been included. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Disinfection Technology and Equipment. The drafting units of this standard are Tianjin University, Guangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration, and Shandong Xinhua Medical Device Co., Ltd.
The main drafters of this standard are Sun Duoxian, Wu Yiming, Mo Cheng, and Yang Zhaoxin. G
GB 18282. 1—2000
ISOForeword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (IS() member bodies). The work of formulating international standards is usually completed by ISO's technical committees. If each member group is interested in the standard items 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 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 if it obtains the consent of at least 75% of the member groups participating in the vote. International Standard ISO11140-1 was formulated by ISO/TC198 Technical Committee on Sterilization of Healthcateproducts.
IS011140 includes the following parts under the general heading "Sterilization of health care products - Chemical indicators": Part 1: General
Part 2: Test equipment and methods
Part 3: Class indicators - Steam penetration test pieces Part 4: Low-density article penetration test apparatus intended for use in sterilizers for non-porous articles using a parametric release method 632
GB18282.12000
This standard specifies the requirements for chemical indicators intended for use in processes using steam, ethylene oxide, gamma or gamma irradiation, steam-irradiation or dry heat for sterilization. For indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization), this standard does not specifically list additional requirements, but the requirements of this general standard should be applied.
Requirements for specific test indicators (e.g. Bowic-Dick test indicators) will be included in other parts of this standard. The test methods and equipment described in ISO11140-2 may be used to determine compliance with the performance requirements specified in this standard. 633
National Standard of the People's Republic of China
Sterilization of health care products-Chemical indicatorsPart 1:General requirements
1 Scope
GB 18282.1-2000
idt ISO 11140-1:1995
This standard specifies the performance requirements for chemical indicators that indicate the sterilization process by showing physical and/or chemical changes in the substance after exposure to the sterilization process.
Note 1: These indicators are used to detect the presence or obtain one or more parameters that meet the requirements of the sterilization process, or to perform various specific tests on sterilization equipment.
This standard also includes acceptance criteria for determining whether the indicators comply with this standard. Note 2: Related test methods and equipment are described in 150111402. Note 3: Additional requirements for (class II) penetration test indicators are given in TS (111) 4[-3 and ISO11140-4 standards. 2 Cited standards
The clauses contained in the following standards constitute the clauses of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised. Parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T7108-1994 Data element and exchange format information interchange H period and time representation (eqVIS08601: 1988) GB18281.1--2000 Biological indicators for sterilization of health care products Part 1: General rules (id1.ISO11138-1: 1994) GB 18281.2-2000
Biological indicators for sterilization of health care products Part 2: Biological indicators for ethylene oxide sterilization (idtIS0 11138-2:1994)
GB 18281.3—2000
Biological indicators for sterilization of health care products Part 3: Biological indicators for heat sterilization (idtIS0 11138 3:1995)
GB/T 19001—1994
Quality assurance model for quality system design, development, production, installation and servicing (idtIS0 11138 3:1994)
GB/T 19002—1994
ISO 11140-2 1998
IS0 11140 3:2000
Quality systems Quality assurance model for production, installation and service (idt1S()9001:1994) Sterilization of health care products
Health care products Sterilization
Test pieces
ISO 11140-4
Sterilization of health care products
Chemical indicators…·Part 2: Test apparatus and methods Chemical indicators I - Part 3: Chemical indicators II Chemical indicators
Vapour penetration
Part 4: Low-density object penetration test apparatus intended for use in non-porous object sterilizers using a parametric release method 1) This reference standard is to be published soon.
Approved by the State Administration of Quality and Technical Supervision on December 13, 2000, 634
Implemented on May 1, 2001
3 Definitions
GB 18282. 12000
The following definitions are used in all parts of GB18282-ISO) II140. 3.1 Endpoint
The visible change of an indicator after exposure to a predetermined physical condition, as specified by the manufacturer. 3.2 Indicator
The combination of an indicator and its substrate in the form of intended use. Note 4: "Indicator" refers to various forms of indicating devices, including indicator cards, sheets, tapes, belts, and devices. The definitions of various types of indicators are given in Chapter 4 of this standard. 3.3 Indicatoragent
The combination of activation elements or elements.
3.4 Saturated steam
Steam with a dryness between 0.85 and 1.0 (i.e., liquid water content of not more than 15% [m/m], and temperature corresponding to the vaporization pressure).
3.5 Critical parameters Observation parameters essential to the sterilization process (and the monitoring required). 3.6 Stated value
The value or range of parameter values set to produce a response in the indicator. 4 Classification of indicators
4.1 Class I: process indicators
The following process indicators are intended for use with individual units (e.g., bags, boxes) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between treated and untreated units.
4.2 Class II: Indicators for specific tests This type of indicator is dedicated to specific test steps specified in the corresponding sterilizer or sterilization standard. Note 5: Requirements for specific test indicators (Class II indicators) will be specified in other parts of GB18282·IS011140. 4.3 Class III; Single parameter indicators
Single parameter indicators are dedicated to one evaluation parameter (see 3.5 and 5.1). They should indicate that a certain calibration value of the selected parameter is reached after exposure to a certain sterilization period.
4.4 Class IV: Multiple parameter indicators
Multiple parameter indicators are dedicated to two or more parameters (see 3.5 and 5.1). They should indicate that a certain calibration value of each selected parameter is reached after exposure to a certain sterilization cycle.
4.5 Category V; Comprehensive Indicators
Comprehensive indicators are indicators that are specifically used to act on all evaluation parameters within the specified range of each sterilization cycle. Their calibration values are required to achieve the specified sterilization, and can refer to the rated D values and values of the specified test microorganisms (such as the description of biological indicators for ethylene oxide sterilization in GB18281.2-IS0111382 and biological indicators for moist heat sterilization in (R18281.3-IS011138-3).
4.6 Category VI: Simulated indicators (cycle verification indicators) Simulated indicators are indicators that are specifically used to act on all evaluation parameters within the specified range of each sterilization cycle, and their calibration values are based on the set values of each selected sterilization cycle. 5 General requirements
The requirements specified in this chapter apply to all indicators, except those specifically included or modified in the subsequent chapters or additional parts of GB18282-IS011140.
GB 18282. 1—2000
5.1 For each continuous sterilization process, the following parameters are defined as evaluative parameters: Steam: time, temperature and steam saturation. Dry heat: time and degree.
Ethylene oxide (E0): time, temperature, humidity and FO concentration. Radiation: total absorbed dose.
Steam formalin: time, temperature, humidity and formalin concentration Note 6: Other factors may also affect the efficacy of the sterilization process. 5.2 The manufacturer shall establish, specify and maintain its formal quality system in accordance with GB/T19001 and (or) GB/T19002, including all operations required to produce a certain product in accordance with this standard GB18282.1-ISO11140-1. 5.3 The changes in the indicator when exposed to the specified conditions shall be clearly observed. 5.4 It shall be clearly marked to indicate the type of sterilization process for which each indicator is intended. The abbreviations for processes are as follows:
All steam sterilization processes
All dry heat sterilization processes
All ethylene oxide sterilization processes
All ionizing radiation sterilization processes
All steam·formalin sterilization processes
Descriptions should use symbols instead of text: When this information cannot be indicated due to limitations on the size and form of the indicator, it should be clearly indicated in the single-page instruction manual or packaging unit. 5.5 If the indicator used is limited to a specific sterilization cycle, the instructions or code should be marked on the product (such as steam 15 minutes at 121°C).
5.6 Each package of indicator or technical instruction leaflet supplied with the packaging box should indicate: a) the expected change; for color-changing indicators whose color changes are difficult to explain, provide samples of the color-changed and non-color-changed indicators within the expected color range:
6) The evaluation parameters of the indicator relative to the bottom and their applicable values: c) Indicator type (classification), marked as process indicator, special test indicator, single parameter indicator, multiple parameter indicator, comprehensive indicator and simulation indicator:
d) Storage conditions:
e) Production period: Storage period and expiration date under certain storage conditions, marking should comply with GB/T 7408 standard provisions (i.e.: × year × month × day);
f) Numbers or codes that can trace the production process g) Necessary instructions for use to ensure the reasonable use of the indicator; h) Various interfering substances or situations that may be encountered or may occur during the intended use of the indicator and may have an adverse effect on the performance of the indicator:
i) The use period and (or) the supplementary safety measures to be taken after use; i) The name and address of the manufacturer or supplier; k) If the indicator is to be kept as part of the record, the storage conditions of the indicator after use; 1) When storing the indicator that is completely changed or not completely changed according to the manufacturer's instructions, the nature of any changes that may occur; i1) If any, the relationship between the corresponding values of the measured evaluation parameters. 5.7 The manufacturer should have a certificate 5 to prove that the indicator does not release any known toxic substances that may harm health or the set performance of the sterilized product before, during and after the specified sterilization process. The requirements of relevant Chinese regulations or corresponding international standards should be adopted. 5.8 If all evaluation conditions for the indicator to produce an endpoint reaction during exposure to the sterilization process have been met or exceeded, the indicator after the change will not result in a judgment different from that when it was removed from the sterilizer when stored for at least six pieces as specified by the manufacturer. 636
GB18282.1—2000
Indicators that have not completely changed will deteriorate during storage, either returning to their pre-change state or slowly changing to the specified endpoint state. If such changes occur, they should be explained in the technical instructions provided by the manufacturer. Such indicators are not suitable for permanent record use.
5.9 When the test is carried out using equipment and methods in accordance with ISO11140-2, the results can be considered to be sufficient to determine compliance with the requirements of this standard, except for radiation indicators.
6 Additional requirements for process indicators (class 1) Note 7: Process indicators can be printed on the packaging material, or provided in the form of self-adhesive labels, packaging tapes, labels, insert labels, etc. 6.1 Indicators for steam sterilization process
6.1.1 After the indicator is exposed to the previously stabilized 140℃±2℃ heat condition for 30min to 1min, it shall show no change or the change shown shall be obviously different from the change after exposure to the steam sterilization process. 6.1.2 Before the indicator is exposed to saturated steam at 121℃+3℃ for at least 3min or 134℃+3℃ for 30min, its display shall indicate that the end point of exposure to the steam sterilization process has not been reached. 6.1.3 When the indicator is exposed to dry saturated steam at 121℃:+3℃ for no more than 10min or 134℃+3℃ for no more than 2min, it shall clearly and intuitively show the change after exposure to the steam sterilization process. 6.2 Indicators for dry heat sterilization process
6.2.1 Before the indicator is exposed to the previously stabilized 160℃±5℃ dry heat condition for no less than 20min, its display shall indicate that the end point of exposure to the heat sterilization process has not been reached.
6.2.2 When the indicator is exposed to the previously stabilized 160℃+5℃ heat condition for no more than 40 minutes, its indication shall indicate that the end point of exposure to the heat sterilization process has been reached.
6.3 Indicator for ethylene oxide sterilization process
6.3.1 After the indicator is exposed to 60℃±2℃ and relative humidity greater than 85% for no less than 90 minutes, it shall show no change or the change shown shall be significantly different from the change after exposure to the ethylene oxide sterilization process. This test requires no addition of ethylene oxide, so it should not be conducted in a sterilizer containing ethylene oxide, because a small amount of ethylene oxide gas may exist in the sterilizer.
6.3.2 Before the indicator is exposed to 600mg/L±30mg/L ethylene oxide and at 30℃±1℃ and relative humidity 60%+10% for at least 5 minutes, its indication shall indicate that the end point of exposure to the ethylene oxide sterilization process has not been reached. 6.3.3 The indicator shall be considered to have reached the end point of the exposure to ethylene oxide sterilization process when the indicator is exposed to ethylene oxide 600 mg/T. = 30 mg/T and at 30℃ + 1℃ and relative humidity 60% ± 10% for no more than 30 minutes. The effect of some ethylene oxide indicators will be weakened when carbon monoxide or other gases are involved. This situation will occur when the composition is such. Therefore, the indicator should be tested in a device using a mixture of not less than 80% carbon monoxide or other gas and ethylene oxide.
6.4 Indicators for ionizing radiation sterilization process
6.4.1 When the indicator is exposed to ultraviolet light (235nm to 280nm) with a surface intensity of not less than 3.3W/m for not less than 12 minutes, the product shall show no change or a significant change that is significantly different from the change after exposure to ionizing radiation sterilization process. 6.4.2 Before the indicator is exposed to an absorbed dose of less than 1 kGy, its display should indicate that the end point of exposure to the radiation sterilization process has been reached. 6.4.3 After the indicator has been subjected to an absorbed dose of no more than 5 kGy, it should clearly and intuitively indicate that it has been exposed to the sterilization process. 6.5 Steam-formalin sterilization process indicator 6.5.1 The indicator should be exposed to 80℃±2C saturated steam for no less than 90 minutes. It should show no change or the change shown should be significantly different from the change after exposure to the steam-formalin sterilization process. This test requires no formalin, so it should not be carried out in a steam-formalin sterilizer because a small amount of this gas or its polymers can exist in the sterilizer.
6.5.2 After the indicator is exposed to 80℃±2C dry heat for no less than 90 minutes, its final display should be no change or the change shown should be significantly different from the change after exposure to the steam-formalin sterilization process, GB 18282. 1—2000
6.5.3 Before the indicator is exposed to 10mg/L ± 2mg/L formalin in 70℃ + 2℃ steam for not less than 5min, its display shall indicate that the endpoint of exposure to the steam-formalin sterilization process has not been reached. 6.5.4 When the indicator is exposed to 10mg/l ± 2mg/L formalin in 70℃ + 2℃ saturated steam for not more than 20min, its display can be considered to have reached the endpoint of exposure to the steam-formalin sterilization process. 6.5.5 For indicators produced for steam-formalin sterilization cycles below 65℃, the tests described in 6.5.3 and 6.5.4 shall be carried out at the maximum temperature and formalin concentration specified by the manufacturer of the indicator. 7 Additional requirements for single parameter indicators (Class III) 7.1 Single parameter indicators shall be dedicated to one evaluation parameter listed in 5.1. 7.2 Single parameter indicators shall undergo a clear and perceptible change, indicating exposure to a sterilization cycle that has reached a predetermined value within the corresponding tolerance range listed in Table 1.
7.3 The specified parameter shall be indicated or coded on the product. 7.4 The calibration value when the indicator reaches its endpoint shall be indicated or coded on the product. 8 Additional requirements for multi-parameter indicators (Class IV) 8.1 Multi-parameter indicators shall be dedicated to two or more evaluation parameters that affect the effectiveness of the monitored sterilization process. 8.2 Multi-parameter indicators shall undergo a clear and perceptible change, indicating exposure to a sterilization cycle that has reached each specified parameter within the corresponding tolerance range listed in Table 1.
8.3 Each specified parameter shall be indicated or coded on the product. 8.4 Each calibration value when the indicator reaches its endpoint shall be indicated or coded on the product. Table 1 Tolerances and limits for evaluation parameters of Class III and Class IV indicators Sterilization method
Ethylene oxide
Steam-Formaldehyde
SV31-2%
1)LL-lower dryness value (lower dryness value)
2)UL-upper dryness value (ultra-high dryness value)
Gas concentration
Relative humidity limit
3)SV=calibrated value: indicates the product's response to a set of evaluation parameters and shall be indicated or coded on the product. ) and the saturation limit are the steam supplied to sterilize the air. 9 Additional requirements for integrated indicators (Class V) Saturation limit 4
9.1 The integrated indicator shall undergo a continuous, perceptible change indicating exposure to a sterilization cycle that has reached the corresponding tolerance range for each specified parameter listed in Table 2.
9.2 Each calibration value shall be indicated or coded on the product. 9.3 The exposure required to effect a change in the indicator should be related to a theoretical microbial inactivation with a calibrated K value and Z value (see 4.5). These values should not be lower than those specified in the appropriate parts of ISO 11138 for various biological indicators used for routine monitoring of the relevant sterilization process. The theoretical inactivation of the microorganism should be specified as a percentage reduction in the total number, expressed as a logarithm.
ISO 11138.12000
9.4 The manufacturer should clearly state any factors that have been noted to have an adverse effect on the sterilization process that cannot be detected by the indicator or that cannot be detected by ensuring that the evaluation parameter or characteristic is met. Proof 8: A similar statement is given as follows:
This indicator will not react in the absence of water vapor, but it is not necessary to specify that a maximum humidity indicator is required to achieve a good reaction. This should be verified by other means. ”
10 Additional requirements for analog indicators (class VI) 10.1 Analog indicators shall undergo clear and perceptible changes, indicating exposure to a sterilization cycle that has reached the corresponding tolerance range of each specified parameter listed in Table 3.
10.2 Each calibration value shall be indicated or coded on the product. Table 2 Tolerances and limits of evaluation parameters for class V indicators Sterilization method
Ethylene oxide
Yanqi-formalin
1) 1.1.=Lower limit (dryness value)
2) 1.=Upper limit (dryness value)
Gas concentration
Relative limit value
3) SV2 marks the product's reaction value for a certain evaluation parameter. The date or code should be marked on the product. 4) Saturation limit value refers to the steam supplied to the sterilization chamber. Saturation limit value\
10.3 The manufacturer should clearly state any factors that have been noticed that may have an adverse effect on the sterilization process, but cannot be detected by the indicator. Or factors that cannot be detected by ensuring that the evaluation parameter or characteristic is met. 9; A similar statement, for example, is as follows
"This indicator cannot react in the absence of water quality gas, but it is not necessary to specify that an optimal humidity indicator is required to achieve a good reaction. This should be verified by other methods."
Note 10: Installation 3 does not list requirements for indicators such as steam-formalin because there is not enough data to set its limits. 10.4 Below is an example of a multi-parameter indicator. Example:
Steam sterilization indicator
calibration value: 3.5 min, 134°C.
To reach the endpoint, the required time should be at least 2.7 min, the temperature should be 132°C, and the dryness should be between 0.85 and 1.0. Any time less than 2.7 min and any temperature below 132°C will not allow the indicator to reach its endpoint. If the time is 3.5 min or more, the temperature is 134°C or higher, and the dryness is between 0.85 and 1.0, the indicator will definitely reach its endpoint. Example 2:
Steam sterilization indicator
calibration value: 15 min, 121°C, saturated steam, the indicator requires the dryness of the steam to be between 0.85 and 1.0, and at least 11.3 min at a temperature of 119°C or higher to reach its endpoint. If the time is 11.7min or longer, the temperature is 119℃, and the dryness value is between 0.85 and 1.0, the indicator will definitely reach its endpoint.
Example 3:
Ethylene oxide (bacteria) indicator
Calibration value: 60 min, 900 mg/L
GB 18282. 1-2000
If the time is less than 45min and (or) the gas concentration is lower than 675mg/L, and the relative humidity is greater than 30%, the indicator will not reach its endpoint. If the time is 60min or longer, the ethylene oxide concentration is 900mg/ or higher, and the relative humidity is greater than 30%, the indicator will definitely reach its endpoint. Table 3: Tolerance and limit values of six types of indicator evaluation parameters
Sterilization method
Ethylene oxide
.sV-5.%
1)LL=lower limit (tenderness value)
2)L—upper limit (dryness value)
Gas concentration
sv in%
Weight is limited to humidity
3)S7=calibration value: mark the product's response value to a certain evaluation value, which should be marked on the product or coded 4) Saturation limit value refers to the steam supplied to the sterilization chamber. 640
Saturation limit value\4 The calibration values when the indicator reaches its endpoint shall be indicated on the product or coded. Table 1 Tolerances and limits of evaluation parameters for Class III and Class IV indicators Sterilization method
Ethylene oxide
Steam-Formaldehyde
SV31-2%
1)LL-lower dryness value (lower dryness value)
2)UL-upper dryness value (T dryness value)
Gas concentration
Relative humidity limit value
3)SV=calibration value: indicates the product's response value to a set of evaluation parameters, which shall be indicated on the product or coded. ) and the limit value are the steam supplied to sterilize the air. 9 Additional requirements for integrated indicators (Class V) Saturation limit value 4
9.1 The integrated indicator shall undergo a continuous, perceptible change, indicating that it has been exposed to a sterilization cycle that has reached each of the specified parameters within the corresponding tolerance range listed in Table 2.
9.2 Each calibration value shall be indicated on the product or coded. 9.3 The exposure required to affect the change of the indicator shall be related to the theoretical inactivation of a microorganism with a calibration value of K and Z (see 4.5). These values shall not be lower than those specified in the corresponding parts of GB 18281--ISO 11138 for various biological indicators used for routine monitoring of the relevant sterilization process. The theoretical inactivation of the microorganism shall be specified as a percentage reduction in the total number, expressed as a logarithm.
GB 18282. 12000
9.4 The manufacturer shall clearly state any factors that have been noted to have an adverse effect on the sterilization process that cannot be monitored by the indicator or that cannot be monitored by ensuring that the evaluation parameters or characteristics are met. Proof 8: Similar statements, for example, are as follows:
This indicator does not react in the absence of water vapor, but it is not necessary to specify that a minimum humidity indicator is required to achieve a good reaction. This should be calibrated by other methods. ”
10 Additional requirements for simulated indicators (class VI) 10.1 The simulated indicator shall undergo a clear and perceptible change, indicating exposure to a sterilization cycle within the corresponding tolerance range of each specified parameter listed in Table 3.
10.2 Each calibration value shall be marked or coded on the product. Table 2 Tolerances and limits for evaluation parameters of class V indicators Sterilization method
Ethylene oxide
Vapor-formalin
1) 1.1.=Lower limit (dryness value)
2) 1.=Upper limit (dryness value)
Gas humidity
Relative limit value
3) SV2 marks the product's reaction value for a certain evaluation parameter. The date or code should be marked on the product. 4) Saturation limit value refers to the steam supplied to the sterilization chamber. Saturation limit value\
10.3 The manufacturer should clearly state any factors that have been noticed that may have an adverse effect on the sterilization process, but cannot be detected by the indicator. Or factors that cannot be detected by ensuring that the evaluation parameter or characteristic is met. 9; A similar statement, for example, is as follows
"This indicator cannot react in the absence of water quality gas, but it is not necessary to specify that an optimal humidity indicator is required to achieve a good reaction. This should be verified by other methods."
Note 10: Installation 3 does not list requirements for indicators such as steam-formalin because there is not enough data to set its limits. 10.4 Below is an example of a multi-parameter indicator. Example:
Steam sterilization indicator
calibration value: 3.5 min, 134°C.
To reach the endpoint, the required time should be at least 2.7 min, the temperature should be 132°C, and the dryness should be between 0.85 and 1.0. Any time less than 2.7 min and any temperature below 132°C will not allow the indicator to reach its endpoint. If the time is 3.5 min or more, the temperature is 134°C or higher, and the dryness is between 0.85 and 1.0, the indicator will definitely reach its endpoint. Example 2:
Steam sterilization indicator
calibration value: 15 min, 121°C, saturated steam, the indicator requires the dryness of the steam to be between 0.85 and 1.0, and at least 11.3 min at a temperature of 119°C or higher to reach its endpoint. If the time is 11.7min or longer, the temperature is 119℃, and the dryness value is between 0.85 and 1.0, the indicator will definitely reach its endpoint.
Example 3:
Ethylene oxide (bacteria) indicator
Calibration value: 60 min, 900 mg/L
GB 18282. 1-2000
If the time is less than 45min and (or) the gas concentration is lower than 675mg/L, and the relative humidity is greater than 30%, the indicator will not reach its endpoint. If the time is 60min or longer, the ethylene oxide concentration is 900mg/ or higher, and the relative humidity is greater than 30%, the indicator will definitely reach its endpoint. Table 3: Tolerance and limit values of six types of indicator evaluation parameters
Sterilization method
Ethylene oxide
.sV-5.%
1)LL=lower limit (tenderness value)
2)L—upper limit (dryness value)
Gas concentration
sv in%
Weight is limited to humidity
3)S7=calibration value: mark the product's response value to a certain evaluation value, which should be marked on the product or coded 4) Saturation limit value refers to the steam supplied to the sterilization chamber. 640
Saturation limit value\4 The calibration values when the indicator reaches its endpoint shall be indicated on the product or coded. Table 1 Tolerances and limits of evaluation parameters for Class III and Class IV indicators Sterilization method
Ethylene oxide
Steam-Formaldehyde
SV31-2%
1)LL-lower dryness value (lower dryness value)
2)UL-upper dryness value (T dryness value)
Gas concentration
Relative humidity limit value
3)SV=calibration value: indicates the product's response value to a set of evaluation parameters, which shall be indicated on the product or coded. ) and the limit value are the steam supplied to sterilize the air. 9 Additional requirements for integrated indicators (Class V) Saturation limit value 4
9.1 The integrated indicator shall undergo a continuous, perceptible change, indicating that it has been exposed to a sterilization cycle that has reached each of the specified parameters within the corresponding tolerance range listed in Table 2.
9.2 Each calibration value shall be indicated on the product or coded. 9.3 The exposure required to affect the change of the indicator shall be related to the theoretical inactivation of a microorganism with a calibration value of K and Z (see 4.5). These values shall not be lower than those specified in the corresponding parts of GB 18281--ISO 11138 for various biological indicators used for routine monitoring of the relevant sterilization process. The theoretical inactivation of the microorganism shall be specified as a percentage reduction in the total number, expressed as a logarithm.
GB 18282. 12000
9.4 The manufacturer shall clearly state any factors that have been noted to have an adverse effect on the sterilization process that cannot be monitored by the indicator or that cannot be monitored by ensuring that the evaluation parameters or characteristics are met. Proof 8: Similar statements, for example, are as follows:
This indicator does not react in the absence of water vapor, but it is not necessary to specify that a minimum humidity indicator is required to achieve a good reaction. This should be calibrated by other methods. ”
10 Additional requirements for simulated indicators (class VI) 10.1 The simulated indicator shall undergo a clear and perceptible change, indicating exposure to a sterilization cycle within the corresponding tolerance range of each specified parameter listed in Table 3.
10.2 Each calibration value shall be marked or coded on the product. Table 2 Tolerances and limits for evaluation parameters of class V indicators Sterilization method
Ethylene oxide
Vapor-formalin bZxz.net
1) 1.1.=Lower limit (dryness value)
2) 1.=Upper limit (dryness value)
Gas humidity
Relative limit value
3) SV2 marks the product's reaction value for a certain evaluation parameter. The date or code should be marked on the product. 4) Saturation limit value refers to the steam supplied to the sterilization chamber. Saturation limit value\
10.3 The manufacturer should clearly state any factors that have been noticed that may have an adverse effect on the sterilization process, but cannot be detected by the indicator. Or factors that cannot be detected by ensuring that the evaluation parameter or characteristic is met. 9; A similar statement, for example, is as follows
"This indicator cannot react in the absence of water quality gas, but it is not necessary to specify that an optimal humidity indicator is required to achieve a good reaction. This should be verified by other methods."
Note 10: Installation 3 does not list requirements for indicators such as steam-formalin because there is not enough data to set its limits. 10.4 Below is an example of a multi-parameter indicator. Example:
Steam sterilization indicator
calibration value: 3.5 min, 134°C.
To reach the endpoint, the required time should be at least 2.7 min, the temperature should be 132°C, and the dryness should be between 0.85 and 1.0. Any time less than 2.7 min and any temperature below 132°C will not allow the indicator to reach its endpoint. If the time is 3.5 min or more, the temperature is 134°C or higher, and the dryness is between 0.85 and 1.0, the indicator will definitely reach its endpoint. Example 2:
Steam sterilization indicator
calibration value: 15 min, 121°C, saturated steam, the indicator requires the dryness of the steam to be between 0.85 and 1.0, and at least 11.3 min at a temperature of 119°C or higher to reach its endpoint. If the time is 11.7min or longer, the temperature is 119℃, and the dryness value is between 0.85 and 1.0, the indicator will definitely reach its endpoint.
Example 3:
Ethylene oxide (bacteria) indicator
Calibration value: 60 min, 900 mg/L
GB 18282. 1-2000
If the time is less than 45min and (or) the gas concentration is lower than 675mg/L, and the relative humidity is greater than 30%, the indicator will not reach its endpoint. If the time is 60min or longer, the ethylene oxide concentration is 900mg/ or higher, and the relative humidity is greater than 30%, the indicator will definitely reach its endpoint. Table 3: Tolerance and limit values of six types of indicator evaluation parameters
Sterilization method
Ethylene oxide
.sV-5.%
1)LL=lower limit (tenderness value)
2)L—upper limit (dryness value)
Gas concentration
sv in%
Weight is limited to humidity
3)S7=calibration value: mark the product's response value to a certain evaluation value, which should be marked on the product or coded 4) Saturation limit value refers to the steam supplied to the sterilization chamber. 640
Saturation limit value\This should be verified by other methods.
Note 10: Specification 3 does not list requirements for indicators such as steam-formalin because there are insufficient data to appropriately set limits. 10.4 Below is an example of such a multiple parameter indicator:
Steam sterilization indicator
Calibration values: 3.5 minutes, 134°C.
To reach the endpoint, the required time should be at least 2.7 minutes, the temperature should be 132°C, and the dryness should be between 0.85 and 1.0. Any time less than 2.7 minutes and any temperature less than 132°C will not allow the indicator to reach its endpoint. If the time is 3.5 minutes or more, the temperature is 134°C or higher, and the dryness is between 0.85 and 1.0, the indicator will definitely reach its endpoint. Example 2:
Steam sterilization indicator
Calibration value: 15 min, 121 t, saturated steam, the indicator requires the dryness of the steam to be between 0.85 and 1.0, and at least 11.3 min at a temperature of 119°C or higher to reach its endpoint. If the time is 11.7 tuin or longer, the temperature is 119°C, and the dryness value is between 0.85 and 1.0, the indicator will definitely reach its endpoint.
Example 3:
Ethylene oxide (bacteria) indicator
Calibration value: 60 min, 900 mg/L
GB 18282. 1-2000
If the time is less than 45 min and (or) the gas concentration is less than 675 mg/L, and the relative humidity is greater than 30%, the indicator will not reach its endpoint. If the time is 60 minutes or longer, the ethylene oxide concentration is 900 mg/ or higher, and the relative humidity is greater than 30%, the indicator will definitely reach its endpoint. Table 3 Tolerances and limit values of the evaluation parameters of the six types of indicators
Sterilization method
Ethylene oxide
.sV-5.%
1)LL=lower limit (tenderness value)
2)L—upper limit (dryness value)
Gas concentration
sv in%
V humidity limit
3)S7=calibration value: mark the product's response value to a certain evaluation value, which should be marked on the product or coded4) Saturation limit refers to the steam supplied to the sterilization chamber. 640
Saturation limit\This should be verified by other methods.
Note 10: Specification 3 does not list requirements for indicators such as steam-formalin because there are insufficient data to appropriately set limits. 10.4 Below is an example of such a multiple parameter indicator:
Steam sterilization indicator
Calibration values: 3.5 minutes, 134°C.
To reach the endpoint, the required time should be at least 2.7 minutes, the temperature should be 132°C, and the dryness should be between 0.85 and 1.0. Any time less than 2.7 minutes and any temperature less than 132°C will not allow the indicator to reach its endpoint. If the time is 3.5 minutes or more, the temperature is 134°C or higher, and the dryness is between 0.85 and 1.0, the indicator will definitely reach its endpoint. Example 2:
Steam sterilization indicator
Calibration value: 15 min, 121 t, saturated steam, the indicator requires the dryness of the steam to be between 0.85 and 1.0, and at least 11.3 min at a temperature of 119°C or higher to reach its endpoint. If the time is 11.7 tuin or longer, the temperature is 119°C, and the dryness value is between 0.85 and 1.0, the indicator will definitely reach its endpoint.
Example 3:
Ethylene oxide (bacteria) indicator
Calibration value: 60 min, 900 mg/L
GB 18282. 1-2000
If the time is less than 45 min and (or) the gas concentration is less than 675 mg/L, and the relative humidity is greater than 30%, the indicator will not reach its endpoint. If the time is 60 minutes or longer, the ethylene oxide concentration is 900 mg/ or higher, and the relative humidity is greater than 30%, the indicator will definitely reach its endpoint. Table 3 Tolerances and limit values of the evaluation parameters of the six types of indicators
Sterilization method
Ethylene oxide
.sV-5.%
1)LL=lower limit (tenderness value)
2)L—upper limit (dryness value)
Gas concentration
sv in%
V humidity limit
3)S7=calibration value: mark the product's response value to a certain evaluation value, which should be marked on the product or coded4) Saturation limit refers to the steam supplied to the sterilization chamber. 640
Saturation limit\
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