GB/T 33420-2016Evaluation standard of biological for moist heat sterilization processes (English PDF)
压力蒸汽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 33420-2016 is the English-translated version of 压力蒸汽灭菌生物指示物检验方法.
GB/T 33420-2016 is the Chinese standard "Evaluation standard of biological for moist heat sterilization processes". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — GB/T 33420-2016
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 Carrier
- 3.5 D value
- 3.6 Survival curve
- 3.7 Biological indicator resistance tester
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
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
The time required to kill 90% of the total number of specific test microorganisms under the set exposure conditions.
3.6 Survival curve
Under the action of immobilized sterilization factors, the association between the survival of microbes and exposure changes.
3.7 Biological indicator resistance tester
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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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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