GB/T 18281.2-2024_English: PDF (GB/T18281.2-2024)
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Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
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Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
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Sterilization of health care products. Biological indicators. Part 2: Biological indicators for ethylene oxide sterilization
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| Standard ID | GB/T 18281.2-2024 (GB/T18281.2-2024) | | Description (Translated English) | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 10,113 | | Date of Issue | 2024-11-28 | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB 18281.2-2015 | | Drafting Organization | Lingbo Medical (Hangzhou) Medical Technology Co., Ltd., Shandong Xinhua Medical Equipment Co., Ltd., Xinxiang Huaxi Medical Materials Co., Ltd., 3M China Co., Ltd., Guangdong Medical Equipment Quality Supervision and Inspection Institute, Hangzhou Younik Disinfection Equipment Co., Ltd., Hangzhou Fujie Disinfection Products Co., Ltd. | | Administrative Organization | National Technical Committee for Standardization of Disinfection Technology and Equipment (SAC/TC 200) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | | Standard ID | GB 18281.2-2015 (GB18281.2-2015) | | Description (Translated English) | Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 12,169 | | Date of Issue | 2015-12-10 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | GB 18281.2-2000 | | Quoted Standard | GB 18281.1-2015; GB/T 24628-2009 | | Adopted Standard | ISO 11138-2-2006, IDT | | Drafting Organization | State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center; 3M China Ltd.; Hangzhou gifted Nick Disinfection Equipment Co., Ltd. | | Administrative Organization | National disinfection technology and equipment Standardization Technical Committee (SAC/TC 200) | | Regulation (derived from) | National Standard Announcement 2015 No.38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This standard specifies requirements for test organisms and test methods proposed in the evaluation of the performance of sterilizers and sterilization processes used, the bacterial suspension, the carrier contamination, biological indicator, which uses pure ethylene oxide sterilization or it is diluted with other gases mixed sterilized sterilization temperature range is 29 �� ~ 65 ��. | | Standard ID | GB 18281.2-2000 (GB18281.2-2000) | | Description (Translated English) | Sterilization of health care products. Biological indicators. Part 2: Biological indicators for ethylene oxide sterilization | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 8,833 | | Date of Issue | 2000-12-13 | | Date of Implementation | 2001-05-01 | | Quoted Standard | GB 18281.1-2000 | | Adopted Standard | ISO 11138-2-1994, IDT | | Drafting Organization | Power of sterilization plant in Hangzhou | | Administrative Organization | National disinfection technology and equipment Standardization Technical Committee | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Quality and Technical Supervision | | Summary | This Chinese standard specifies the intended sterilization performance evaluation test using microorganisms and biological indicators of specific requirements, the use of pure ethylene oxide sterilization gas or mixing it with other diluent gas for sterilization, sterilization temperature range 20 �� ~ 65 ��. |
GB/T 18281.2-2024. Biological indicators for sterilization of healthcare products Part 2. Biological indicators for ethylene oxide sterilization
ICS 11.080.01
CCSC47
National Standard of the People's Republic of China
Replaces GB 18281.2-2015
Sterilization biological indicators for healthcare products
Part 2.Biological indicators for ethylene oxide sterilization
(ISO 11138-2.2017,IDT)
Released on 2024-11-28
2025-12-01 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 1
5 Test microorganisms 1
6 Bacterial suspension 2
7 Carrier and primary packaging 2
8 Contaminated carriers and biological indicators 2
9 Bacterial count and resistance 2
Appendix A (Normative) Method for determination of resistance of biological indicators for ethylene oxide sterilization 3
Appendix B (informative) Specification for the introduction of a second minimum D value for changes in test gas for assessing resistance and deletion of the minimum D value at 30 °C
Reason for request 4
References 5
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is Part 2 of GB/T 18281 "Biological indicators for sterilization of healthcare products". GB/T 18281 has been published
The following parts.
--- Part 1.General;
--- Part 2.Biological indicators for ethylene oxide sterilization;
--- Part 3.Biological indicators for moist heat sterilization;
--- Part 4.Biological indicators for dry heat sterilization;
--- Part 5.Biological indicators for low temperature steam formaldehyde sterilization;
--- Part 7.Guidance for selection, use and result judgment;
--- Part 8.Confirmation method for shortening the incubation time of biological indicators.
This document replaces GB 18281.2-2015 "Biological indicators for sterilization of health care products Part 2.Biological indicators for ethylene oxide sterilization"
Compared with GB 18281.2-2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Deleted the way in which the D value at 30℃ represents resistance (see 9.4 of the.2015 edition);
--- Deleted the requirement that the D value should be ≥ 12.5min at 30℃ (see 9.5 of the.2015 edition);
--- Deleted the description that the resistance of biological indicators can be expressed as FBIO (see 9.6 of the.2015 edition);
--- Added the D value requirements when testing with mixed gas and 100% ethylene oxide gas (see 9.5 and 9.6).
This document is equivalent to ISO 11138-2.2017 "Biological indicators for sterilization of health care products Part 2.Biological indicators for sterilization with ethylene oxide"
Biological Indicators.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Disinfection Technology and Equipment (SAC/TC200).
This document was drafted by. Lingbo Medical (Hangzhou) Medical Technology Co., Ltd., Shandong Xinhua Medical Equipment Co., Ltd., Xinxiang
Huaxi Medical Materials Co., Ltd., 3M China Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Hangzhou Unik Disinfection Equipment Co., Ltd.
Company, Hangzhou Fujie Disinfection Products Co., Ltd.
The main drafters of this document are. Zhou Zhilong, Zhao Jianing, Lin Manting, Cui Wenbo, Zhou Guangyu, Hu Bin, Huang Jingxiong, Wang Zhijing, and Wang Qiang.
The previous versions of this document and the documents it replaces are as follows.
---First issued as GB 18281.2-2000 in.2000 and first revised in.2015;
---This is the second revision.
introduction
GB/T 18281 "Biological Indicators for Sterilization of Healthcare Products" is a general and specific standard for biological indicators.
GB/T 18281 aims to provide requirements for biological indicators, guidelines for selection, use and result judgment, as well as methods for shortening the incubation time.
It consists of eight parts.
--- Part 1.General. The purpose is to provide general requirements for biological indicators.
--- Part 2.Biological indicators for ethylene oxide sterilization. The purpose is to provide a dedicated biological indicator for ethylene oxide sterilization
Require.
--- Part 3.Biological indicators for moist heat sterilization. The purpose is to provide specific requirements for biological indicators for moist heat sterilization.
--- Part 4.Biological indicators for dry heat sterilization. The purpose is to provide specific requirements for biological indicators for dry heat sterilization.
--- Part 5.Biological indicators for low temperature steam formaldehyde sterilization. The purpose is to provide biological indicators for low temperature steam formaldehyde sterilization
Special requirements for
--- Part 6.Biological indicators for hydrogen peroxide sterilization. The purpose is to provide a dedicated biological indicator for hydrogen peroxide sterilization
Require.
--- Part 7.Guidance for selection, use and result interpretation. The purpose is to provide guidance for the correct selection and use of biological indicators.
--- Part 8.Confirmation method for shortening the incubation time of biological indicators. The purpose is to provide a method for shortening the incubation time of biological indicators.
Confirmation method.
GB/T 18281.1 specifies the production, labeling, test methods and performance requirements of biological indicators, which include
This document specifies the specifications for biological indicators used in ethylene oxide sterilization processes.
Use requirements.
This document was developed by experts representing manufacturers, users and regulatory authorities.
The present document does not recommend the use of biological indicators in situations where they are currently in use, but rather provides specifications for biological indicators currently in use.
Requirements for ethylene oxide sterilization validation and routine control are given in ISO 11135 and ISO 14937.
Guidance on the selection, use and result judgment of biological indicators is given in GB/T 18281.7.
Sterilization biological indicators for healthcare products
Part 2.Biological indicators for ethylene oxide sterilization
1 Scope
This document specifies the test microorganisms, bacterial suspensions, contaminated carriers, biological indicators, and
The sterilizer and sterilization process use pure ethylene oxide gas or a mixture of ethylene oxide gas and diluent gas.
The sterilization temperature range is 29℃~65℃.
Note 1.For the requirements for ethylene oxide sterilization validation and control, see ISO 11135 and ISO 14937.
Note 2.Regulations in some countries or regions may give safety requirements for the workplace.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 18281.1-2024 Biological indicators for sterilization of healthcare products Part 1.General principles (ISO 11138-1.2017,
IDT)
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 11138-1 apply.
The terminology databases used for standardization maintained by ISO and IEC are located at.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test microorganisms
5.1 The test microorganisms shall be Bacillus atrophaeus spores, Bacillus subtilis spores or other microorganisms with equivalent performance that have been shown to meet the requirements of this document.
Microbial strains.
Note 1.Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.
Note 2.Bacillus atrophaeus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and ICP77.18 have been found to be suitable
Suitable strains 1).
1) Bacillus atrophaeus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and CIP77.18 are suitable commercially available
This information is given for the convenience of users of this document and does not constitute an endorsement of these products.
......
GB 18281.2-2015
Sterilization of health care products - Biological indicators - Part 2. Biological indicators for ethylene oxide sterilization
ICS 11.080.01
C47
National Standards of People's Republic of China
Replacing GB 18281.2-2000
Sterilization of health care products - Biological indicators
Part 2. Biological indicators for ethylene oxide sterilization was
Part 2. Biologicalindicatorsforethyleneoxidesterilizationprocesses
(ISO 11138-2.2006, IDT)
Issued on. 2015-12-10
2017-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 1 General
1 5 test organisms
6 1 bacterial suspension
7 carrier and primary packaging 2
8 carrier contamination and biological indicators 2
9 Number of microbial resistance and 2
Appendix A (normative) Determination of ethylene oxide sterilization Resistance 3
Reference 4
Foreword
All technical content in this Part of GB 18281 is mandatory.
GB 18281 "Sterilization of health care products - Biological indicators" is divided into five parts.
--- Part 1. General;
--- Part 2. Biological indicators for ethylene oxide sterilization thereof;
--- Part 3. Biological indicators for moist heat sterilization;
--- Part 4. Biological indicators for dry heat sterilization thereof;
--- Part 5. low temperature steam formaldehyde sterilization biological indicators.
This section is part of the 2 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 18281.2-2000 "Sterilization of health care products - Biological indicators - Part 2. ethylene oxide sterilization Health
Was the indicator ", compared with GB 18281.2-2000, the main technical changes are as follows.
Chapter 5 --- improved test organisms;
--- Chapter 9 increased the number of microorganisms requirements;
--- Revised Appendix A.
This section uses the translation method identical with ISO 11138-2.2006 "Sterilization of health care products - Biological indicators - Part 2. Ring
Ethylene oxide sterilization biological indicators. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB 18281.1-2015 Sterilization of health care products - Biological indicators - Part 1. General (ISO 11138-1.2006,
IDT);
--- GB/T 24628-2009 Sterilization of health care products - Biological and chemical indicators of test equipment (ISO 18472.
2006, IDT).
This part made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes;
--- Delete foreword international standards;
--- Introduction of international standards and references appear to replace the corresponding country standards.
Please note that some of the content of this document may involve patents. Issuer of this document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, 3M China Ltd,
Ltd. Hangzhou gifted Nick disinfection equipment.
The main drafters of this section. Lu Wenjuan, Huang Xiulian, Huang Jingxiong.
This part of the standard replaces the previous editions are.
--- GB 18281.2-2000.
introduction
GB 18281.1 provides biological indicator production, labeling, test methods and performance requirements for these indicators is expected to contain sterilized
Ranjun carrier confirmation process and routine control and bacterial suspension. This section provides special procedure for ethylene oxide sterilization of biological indicator
Use requirements.
GB 18281 provides general requirements and test methods. This standard is to participate in professional manufacturers, users and regulators to develop.
The purpose of this standard is not to promote the development in the case is not recommended the use of biological indicators, but for biological indicator currently used to provide
specification.
Ethylene oxide sterilization Validation and routine control See GB 18279.
Select the biological indicator, use and test results to determine see GB/T 19972.
Sterilization of health care products - Biological indicators
Part 2. Biological indicators for ethylene oxide sterilization was
1 Scope
GB 18281 of the provisions of this part of the test organisms intended when evaluating the performance of the sterilizer and sterilization processes used, bacterial suspension, carrying contamination
Body, special requirements and test methods for biological indicator, which uses pure ethylene oxide sterilization or it is mixed with other dilution gas sterilization,
Sterilization temperature range is 29 ℃ ~ 65 ℃.
Note 1. ethylene oxide sterilization confirmation and routine control See GB 18279.
Note 2. workplace safety reference to the relevant provisions of the State.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 11138-1.2006 Sterilization of health care products - Biological indicators - Part 1. General (Sterilizationofhealthcare
products-Biologicalindicators-Part 1. Generalrequirements)
ISO 18472 Sterilization of health care products biological and chemical indicators of test equipment (Sterilizationofhealthcare
products-Biologicalandchemicalindicators-Testequipment)
3 Terms and Definitions
Terms and definitions defined in ISO 11138-1 apply to this document.
4 General
ISO 11138-1 requirements apply to this section.
5 test organisms
5.1 test organisms should shrink Bacillus spores, Bacillus subtilis strains or other requirements of this part of the accord.
Note 1. The original Bacillus subtilis some strains have been reclassified as Bacillus atrophy.
Note 2. It is confirmed that atrophy Bacillus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and is co-CIP77.18
Suitable strains.
5.2 If the test microorganism is not shrinking, Bacillus microbe resistance test should determine suitability.
6 bacterial suspension
ISO 11138-1 requirements apply to this section.
7 carrier and primary packaging
7.1 ethylene oxide sterilization Biological indicators carrier and primary packaging shall conform to ISO 11138-1.2006 required 5.2 and Appendix B of.
7.2 Confirm Biological indicators for ethylene oxide sterilization carrier and primary packaging meets the requirements of the test conditions shall be as follows.
a) Minimum exposure temperature. ≥55 ℃;
b) sterilizing agents. ≥70% relative humidity conditions, the ethylene oxide concentration ≥800mg/L;
c) maximum exposure temperature. specified by the manufacturer;
d) Exposure time. ≥6h.
NOTE. As long as the selected condition is still within the range of effectiveness of the ethylene oxide sterilization process, those conditions are selected to represent the actual inspection of the carrier.
8 carrier contamination and biological indicators
ISO 11138-1 requirements apply to this section.
9 The number and resistance of microorganisms
9.1 The manufacturer shall declare resistance biological indicator meets ISO 11138-1.2006 6.4 requirements.
9.2 biological indicator of viable cells per unit increment should be an integral multiple of ≤0.1 × 10n represented, each unit can be bacteria per ml suspension per
A Ranjun carrier or biological indicator of each piece.
Viable count 9.3 contamination vectors and biological indicator should be ≥1.0 × 106.
9.4 Application D resistance value and 54 ℃/30 ℃, or expressed, in minutes (min). Each batch of biological indicator D value should remain a
Decimals.
9.5 according to the test methods in Appendix A, including atrophy of Bacillus spores suspension, D values of carrier contamination and biological indicators at 54 ℃ when
Should ≥2.5min, and/or at 30 ℃ should ≥12.5min. Other microbes should not affect the D value of its use.
9.6 biological indicator resistance can also be expressed as FBIO (see ISO 11138-1.2006 3.7).
This section and other parts of the resistance properties of GB 18281 are valid under their specific conditions.
9.7 D value according to ISO 11138-1.2006 as specified in Appendix C and Appendix D is determined.
9.8 D value and survival - kill response characteristics of the resistance is determined to use the instrument, using a resistance meter to determine the appropriate process parameters (see Appendix A).
9.9 survival - kill zone can be ISO 11138-1.2006 Annex E calculated formula.
NOTE. This information is for the user when comparing different batches of the same manufacturer product of great value.
Example.
According to ISO 11138-1.2006 Appendix E of the formula, known minimum viable count and the minimum value of D in this section, survival - kill response characteristics are.
--- At 54 ℃ when. survival time ≥10min, kill time ≤25min;
--- At 30 ℃. survival time ≥50min, kill time ≤125min.
Appendix A
(Normative)
Determination of ethylene oxide sterilization resistance
A.1 Overview
This method requires special equipment. resistance meter. Ethylene oxide sterilization process specification resistance instrument parameters, see ISO 18472.
Test method, see A.2.
A.2 Test Method
A.2.1 The sample is placed on a suitable sample loading equipment.
A.2.2 The resistance meter reaction chamber preheated to the test temperature (54 ℃ or 30 ℃).
A.2.3 The carrier injector into the reaction chamber, close the chamber and start processing cycle.
A.2.4 according to the following steps to get started.
Step 1. The reaction chamber is evacuated to 10kPa ± 0.5kPa.
Step 2. access sufficient water vapor, the relative humidity of the reaction chamber was 60% ± 10%. And the conditions were maintained 30min ± 1min.
Before steaming, samples should be allowed to warm to above the dew point to avoid possible formation of condensation water.
Step 3. Go through the interior of the ethylene oxide, reaching 600mg/L ± 30mg/L in the 60s. When the exposure time of 0min, should no
Ethylene oxide fed.
Step 4. The conditions were maintained within the set time of ± 5s.
Step 5. At the end of the exposure period, the reactor chamber is evacuated, down to 10kPa or less in the 60s, and then pass into the filtered air
Or an inert gas (such as nitrogen) to the ambient air pressure.
Step 6. The fifth step was repeated four times.
Step 7. Finally, the sample was removed and placed in culture medium. (See ISO 11138-1.2006 in Chapter 7)
A.2.5 transfer period should be recorded, all tests should be using the same time period.
A.3 resistance determination
Shall be in accordance with ISO 11138-1.2006 Determination of resistance method Appendix C, Appendix D and Appendix E of.
references
[1] GB 18279 (all parts) Sterilization of health care products of ethylene oxide
[2] GB/T 19972-2005 Sterilization of health care products - Biological indicators selection, use and test results to determine Guide
(ISO 14161.2000, IDT)
......
Similar standards: GB/T 18281.1-2024 GB/T 18281.3-2024
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