GB/T 33419-2016Test method of biological indicator for ethylene oxide sterilization processes (English PDF)
环氧乙烷灭菌生物指示物检验方法
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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 33419-2016 is the English-translated version of 环氧乙烷灭菌生物指示物检验方法.
GB/T 33419-2016 is the Chinese standard "Test method of biological indicator for ethylene oxide sterilization processes". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — GB/T 33419-2016
National Standard of the People's Republic of China
- ICS
- 11.080
- Classification
- C 59
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- 1 Scope
- 2 normative reference documents
- 3 terms and definitions
- 3.1 Biological indicator biologicalindicator; BI
- 3.2 Carrier
- 3.3 Indicating microbial testorganism
- 3.4 Viable count
- 3.5 D value
- 3.6 Survival curve
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
Test the support of microbes.
3.3 Indicating microbial testorganism
Microorganisms for the preparation of vector carriers.
3.4 Viable count
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
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
Under the set conditions, the survival of microbes and the changes in exposure to sterilization media curve.
......
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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