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GB/T 33418-2016: Test method of chemical 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 33418-2016 | English | 159 |
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Test method of chemical indicator for ethylene oxide sterilization processes
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GB/T 33418-2016
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Basic data | Standard ID | GB/T 33418-2016 (GB/T33418-2016) | | Description (Translated English) | Test method of chemical indicator for ethylene oxide sterilization processes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C50 | | Word Count Estimation | 8,823 | | Date of Issue | 2016-12-30 | | Date of Implementation | 2017-07-01 | | Quoted Standard | GB/T 19633; ISO 11140-1-2005 | | 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 definition, classification, technical requirements and test methods for ethylene oxide sterilization chemical indicators. This standard applies to the inspection of ethylene oxide sterilization chemical indicators. | GB/T 33418-2016: Test method of chemical 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 chemical indicator for ethylene oxide sterilization processes
ICS 11.080
C50
National Standards of People's Republic of China
Test method for chemical indicators of ethylene oxide 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
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
Category 1
Technical requirements 2
6 Test Method 2
Appendix A (Normative Appendix) Process Indicator Additional Requirements 4
Appendix B (normative) Additional requirements for sterilization effect indicators in the package 5
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. Jiangsu Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health Related Products Safety,
Jiangsu Province Blood Center, National Health and Family Planning Commission Health and Family Planning Supervision Center, Shandong Province Center for Disease Control and Prevention.
The standard drafters. Xu Yan, Wu Xiaosong, Zhang flow, Chen Yueying, Sun Wei, Sun Jun, Duan Yabo, Tan Zhi, Shi Shaoyi, Wang Hongmin,
Chu Hongliang, Liu Yunming, Wang Xiaolei, Sun Qihua.
Test method for chemical indicators of ethylene oxide sterilization
1 Scope
This standard specifies the definition, classification, technical requirements and test methods for ethylene oxide sterilization chemical indicators.
This standard applies to the inspection of ethylene oxide sterilization chemical 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.
GB/T 19633 Final sterilization of medical equipment packaging
Disinfection technical specifications (2002 edition) Ministry of Health
ISO 11140-1..2005 Sterilization of medical products - Chemical indicators - Part 1. General (Sterilization ofhealthcare
products-chemicalindicators
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Color reagent indicatoragent
Activity [a combination of a substance or an active substance that can undergo a specific change in physical and/or chemical changes under certain conditions].
3.2
Chemical Indicator Chemicalindicator
The developer and its substrate form a desired product in a predetermined form.
3.3
End endpoint
By the manufacturer, the visible changes that occur after the indicator is exposed to a predetermined physical and/or chemical condition.
3.4
Parameter value parameter
Used to control some (or several) specific values of the ethylene oxide sterilization process, where time, temperature, relative humidity and ethylene oxide concentration are determined
Meaning as a key parameter.
3.5
Calibration value statedvalue; SV
Set the evaluation parameter value or range of parameter values to cause the indicator to react.
4 classification
4.1 Process indicators
This type of chemical indicator is used to confirm the sterilization process.
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