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GB/T 33417-2016: Test method of biological indicator for hydrogen peroxide vapour sterilization processes
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 33417-2016 | English | 159 |
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Test method of biological indicator for hydrogen peroxide vapour sterilization processes
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GB/T 33417-2016
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Basic data | Standard ID | GB/T 33417-2016 (GB/T33417-2016) | | Description (Translated English) | Test method of biological indicator for hydrogen peroxide vapour sterilization processes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C50 | | Word Count Estimation | 8,881 | | Date of Issue | 2016-12-30 | | Date of Implementation | 2017-07-01 | | Quoted Standard | GB/T 24628; GB 18281.1 | | 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 | | Summary | This standard specifies the method for the detection of hydrogen peroxide gas sterilization biological indicators. This standard applies to the detection of hydrogen peroxide gas sterilization biological indicators. | GB/T 33417-2016: Test method of biological indicator for hydrogen peroxide vapour 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 watts for hydrogen peroxide vapour sterilization processes
ICS 11.080
C50
National Standards of People's Republic of China
Standard Test Method for Hydrogen Peroxide Gas Sterilization Biological Indicator
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
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed by the National Health and Family Planning Commission of the People's Republic of China.
The drafting of this standard. China Center for Disease Control and Prevention Environmental and Health Related Products Safety, the Chinese People's Liberation Army disease prevention and control
Department of Hospital, Chinese Academy of Medical Sciences Union Hospital.
The main drafters of this standard. Zhang flow, Zhang Jian, Yao Chuanshui, Zhang Qing, Wang Lifei, Zhang Wei, Wang Xiang, Wang Hongmin, Shi Shaoyi, Wang Yanyan, Qiu Xia,
Ma Ling, Zhu Tingting.
Standard Test Method for Hydrogen Peroxide Gas Sterilization Biological Indicator
1 Scope
This standard specifies the method for the detection of hydrogen peroxide gas sterilization biological indicators.
This standard applies to the detection of hydrogen peroxide gas 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/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.
3.2
Hydrogen peroxide gas sterilization hydrogenperoxidevapoursterilization
To vaporize hydrogen peroxide as the main way to kill microbial factors sterilization.
3.3
Carrier carrier
Test the support of microbes.
3.4
Survival time;
Determination of biological indicator resistance, the test sample by the bactericidal effect, all the bacteria grow the longest role of time.
3.5
Kill time kiling time;
Determination of biological indicator resistance, the test sample after the role of sterilization factor, the most sterile growth of the shortest duration of action.
3.6
D value Dvalue
The time required to kill the number of microorganisms to reach 90%.
3.7
Self-contained biological indicator self-containedbiologicalindicator
A biological indicator of the medium required for the growth of microbial resuscitation.
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