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GB/T 33420-2016: Evaluation standard of biological for moist heat sterilization processes
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 33420-2016 | English | 159 |
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Evaluation standard of biological for moist heat sterilization processes
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GB/T 33420-2016
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Basic data | Standard ID | GB/T 33420-2016 (GB/T33420-2016) | | Description (Translated English) | Evaluation standard of biological for moist heat sterilization processes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C50 | | Word Count Estimation | 8,824 | | Date of Issue | 2016-12-30 | | Date of Implementation | 2017-07-01 | | Quoted Standard | GB 18281.1; GB/T 24628; ���������淶(2002��)������ | | 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 test method for the pressure steam sterilization biological indicator. This standard applies to the verification of pressure steam sterilization biological indicators. | GB/T 33420-2016: Evaluation standard of biological for moist heat 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.
Evaluation standard of biological for moist heat sterilization processes
ICS 11.080
C50
National Standards of People's Republic of China
Test method for biological indicators of pressure steam sterilization
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
Ltd., Xinhua Medical Devices Co., Ltd., China Academy of Medical Sciences Union Hospital, Shandong Lierkang disinfection Technology Co., Ltd.,
3M China Limited, Hangzhou Ruowao Fu Import & Export Co., Ltd.
The main drafters of this standard. Zhang flow, Zhang Jian, Yao Chuanshui, Zhang Qing, Wang Yanyan, Shen Jin, Huang Jingxiong, Zhu Xiaoming, Zhu Hanquan,
Ma Ling, Ban Haiqun.
Test method for biological indicators of pressure steam sterilization
1 Scope
This standard specifies the test method for the pressure steam sterilization biological indicator.
This standard applies to the verification of pressure steam 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
Carrier carrier
Test the support of microbes.
3.3
Survival time;
Exposed to the bactericidal factor under specified conditions, the maximum time for the microorganisms to survive in the biological indicator of the test.
3.4
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.
3.5
D value Dvalue
The time required to kill 90% of the total number of specific test microorganisms under the set exposure conditions.
3.6
Survival curve survivorcurve
Under the action of immobilized sterilization factors, the association between the survival of microbes and exposure changes.
3.7
Biological indicator resistance tester biologicalindicatorevaluatorresistometer
Produce a limited amount of sterilization process under the conditions specified in the combination of physical and chemical changes to measure the resistance of the special equipment.
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