GB/T 33417-2016Test method of biological indicator for hydrogen peroxide vapour sterilization processes (English PDF)
过氧化氢气体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 33417-2016 is the English-translated version of 过氧化氢气体灭菌生物指示物检验方法.
GB/T 33417-2016 is the Chinese standard "Test method of biological indicator for hydrogen peroxide vapour sterilization processes". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — GB/T 33417-2016
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
- 1 Scope
- 2 normative reference documents
- 3 terms and definitions
- 3.1 Biological indicator biologicalindicator; BI
- 3.2 Hydrogen peroxide gas sterilization
- 3.3 Carrier
- 3.6 D value
- 3.7 Self-contained 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
To vaporize hydrogen peroxide as the main way to kill microbial factors sterilization.
3.3 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
The time required to kill the number of microorganisms to reach 90%.
3.7 Self-contained biological indicator
A biological indicator of the medium required for the growth of microbial resuscitation.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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