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GB/T 40365-2021: General guide for cell sterility testing
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 40365-2021 | English | 119 |
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General guide for cell sterility testing
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GB/T 40365-2021
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Basic data | Standard ID | GB/T 40365-2021 (GB/T40365-2021) | | Description (Translated English) | General guide for cell sterility testing | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A40 | | Word Count Estimation | 6,642 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 40365-2021: General guide for cell sterility testing---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.
General guide for cell sterility testing
ICS 07.080
CCSA40
National Standards of People's Republic of China
General rules for cell sterility testing
Released on 2021-08-20
2022-03-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed and managed by the National Standardization Technical Committee for Biochemical Testing (SAC/TC387).
Drafting organizations of this document. Institute of Zoology, Chinese Academy of Sciences, Beijing Institute of Stem Cell and Regeneration Innovation, Chinese Society for Cell Biology, Beijing
Business University, Institute of Biology, China Institute of Testing Technology, Chinese Academy of Metrology, Institute of Microbiology, Chinese Academy of Sciences, China Food
Institute of Drug Control, Chinese Academy of Medical Sciences, Academy of Military Medicine of the Chinese People’s Liberation Army.
The main drafters of this document. Zhao Tongbiao, Hao Jie, Ma Aijin, Wang Lei, Ding Jinfeng, Hu Baoyang, Cao Jiani, Wang Liu, Zhou Lihua, Zhang Yu, Wei Jun,
Fu Boqiang, Li Qiyuan, Zheng Aihua, Fu Yu, Dong Guanmu, Wang Bin, Wu Xueling, Wei Qiang, Fan Wei, Zhu Huanxin.
General rules for cell sterility testing
1 Scope
This document specifies the general requirements, method selection and process control for cell sterility testing.
This document is applicable to the detection and control of bacteria, fungi, viruses and mycoplasma in cells.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB 19489 Laboratory Biosafety General Requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Sterility testing
The determination of whether there is microbial contamination in a cell sample.
4 Abbreviations
The following abbreviations apply to this document.
ITS1.The first internal transcribed spacer of ribosomal DNA (InternalTranscribedSpacer-1)
ITS2.The second internal transcribed spacer of ribosomal DNA (InternalTranscribedSpacer-2)
MNP. Polynucleotide Polymorphism (MutipleNucleotidePolymorphism)
PCR. Polymerase Chain Reaction (PolymeraseChain Reaction)
16SrRNA. 16S ribosomal RNA (16SRibosomalRibonucleicAcid)
5 General requirements
5.1 The risk assessment of cells should be carried out based on the cell source, potential contamination exposure history, the intended use of the cell and the environment in which it is located.
The factors to be considered include but are not limited to the following aspects.
a) The source of the cell sample should be considered. Cells from different species are likely to carry potential microorganisms;
b) Related contamination testing should be carried out according to the purpose of cell use;
c) The environmental factors in the whole cycle of cell preparation and cell culture should be considered. Evaluate possible contamination based on exposure history, such as
The animal serum of the cultured cells may be contaminated with specific microorganisms.
5.2 Determine the most likely type of microbial contamination based on risk assessment, evaluate the applicability of existing inspection methods, and select samples for testing.
Choose the appropriate method.
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