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GB/T 33419-2016: Test method of biological indicator for ethylene oxide sterilization processes
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 33419-2016 | English | 279 |
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Test method of biological indicator for ethylene oxide sterilization processes
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GB/T 33419-2016
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Basic data | Standard ID | GB/T 33419-2016 (GB/T33419-2016) | | Description (Translated English) | Test method of biological indicator for ethylene oxide sterilization processes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.080 | | Word Count Estimation | 14,138 | | Date of Issue | 2016-12-30 | | Date of Implementation | 2017-07-01 | | Regulation (derived from) | National Standard Notice No.27 of 2016 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | GB/T 33419-2016: Test method of biological indicator for ethylene oxide sterilization processes---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Test method of biological indicator for ethylene oxide sterilization processes
ICS 11.080
C50
National Standards of People's Republic of China
Ethylene oxide sterilization - Biological test method
2016-12-30 release
2017-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Management Committee released
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 technical requirements 2
5 test method 3
Appendix A (Normative Appendix) Resistance Tester Requirements and Resistance Tests 4
Appendix B (Normative Appendix) Method for counting viable culture 5
Appendix C (Normative Appendix) Survival Curve Method for Determining D Values 6
Appendix D (normative) Partial negative analysis for the determination of D values
Appendix E (normative) Verification of D value 10
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and centralized by the Health and Family Planning Commission of the People's Republic of China.
The drafting of this standard. Jiangsu Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health Related Products Safety,
National Health and Family Planning Commission Health and Family Planning Supervision Center, Xuzhou City Center for Disease Control and Prevention.
Standard drafters. Xu Yan, Sun Jun, Wu Xiaosong, Chen Yueying, Zhang Runbo, Duan Yabo, Shi Shaoyi, Wang Hongmin, Huang Jingxiong, Tan Zhi, Zhang Jian,
Wang Ling, Sun Wei, Zhang Wei, Chu Hongliang, Chang Guiqiu.
Ethylene oxide sterilization - Biological test method
1 Scope
This standard specifies the terms and definitions of ethylene oxide sterilization biological indicators, technical requirements and test methods.
This standard applies to the detection of ethylene oxide sterilization biological indicators.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
Health care products - Sterilization - Biological indicators - Part 1. General rules GB 18281.1
GB 18281.2 Sterilization products for health care products - Part 2. Biological indicators for sterilization of ethylene oxide
GB/T 24628 Sterilization products for medical and health products - Test equipment for biological and chemical indicators
Disinfection technical specifications (2002 edition) Ministry of Health
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Biological indicator biologicalindicator; BI
The specific sterilization procedures under the specified conditions have a certain resistance, and installed in the inner packaging available in the bacteria carrier. Contains bacteria tablets
And self-contained biological indicators.
3.2
Carrier carrier
Test the support of microbes.
3.3
Indicating microbial testorganism
Microorganisms for the preparation of vector carriers.
3.4
Viable count viabletestorganismcount
The amount of viable bacteria contained in the sample such as bacterial suspension, bacteria carrier and the like was determined under the prescribed culture conditions. By calculating the growth of a single bacteria
And the number of viable bacteria in the suspension of the unit volume or the bacteria on the carrier.
3.5
D value Dvalue
In the set conditions, kill the number of microorganisms up to 90% of the time required.
Note. The unit is min (min).
3.6
Survival curve survivorcurve
Under the set conditions, the survival of microbes and the changes in exposure to sterilization media curve.
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