GB/T 33418-2016Test method of chemical indicator for ethylene oxide sterilization processes (English PDF)
环氧乙烷灭菌化学指示物检验方法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 30, 2016
Implementation date
July 1, 2017
Scope
GB/T 33418-2016 is the English-translated version of 环氧乙烷灭菌化学指示物检验方法.
GB/T 33418-2016 is the Chinese standard "Test method of chemical indicator for ethylene oxide sterilization processes". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions; classification.
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Document preview — GB/T 33418-2016
National Standard of the People's Republic of China
- ICS
- 11.080
- Classification
- C 50
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 6 Test Method
- Appendix A (Normative Appendix) Process Indicator Additional Requirements
- Appendix B (normative) Additional requirements for sterilization effect indicators in the package
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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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