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GB/T 42466-2023: Technical specification for pluripotent stem cells management of biobanking
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 42466-2023 | English | 269 |
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Technical specification for pluripotent stem cells management of biobanking
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GB/T 42466-2023
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Basic data | Standard ID | GB/T 42466-2023 (GB/T42466-2023) | | Description (Translated English) | Technical specification for pluripotent stem cells management of biobanking | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A01 | | Classification of International Standard | 07.080 | | Word Count Estimation | 14,163 | | Date of Issue | 2023-09-07 | | Date of Implementation | 2023-09-07 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42466-2023: Technical specification for pluripotent stem cells management of biobanking---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.
ICS 07.080
CCSA01
National Standards of People's Republic of China
Technical specifications for the management of pluripotent stem cells in biobanks
Published on 2023-09-07
Implemented on 2023-09-07
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
Preface III
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Abbreviations 2
5 General requirements 3
6 Collection and reception 3
7 Build a relationship 4
8 Resuscitation and Culture 4
9 Freezing and Storage 5
10 Quality Control 5
11 Distribute 6
12 Transport 7
Appendix A (informative) Quality control testing items for human and mouse pluripotent stem cell biobanks 8
Reference 9
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed and coordinated by the National Technical Committee for Standardization of Biological Samples (SAC/TC559).
This document was drafted by. Institute of Zoology, Chinese Academy of Sciences, Beijing Institute of Stem Cells and Regenerative Medicine, Chinese Society of Cell Biology,
Beijing Technology and Business University, Beijing Zehui Chenxing Biotechnology Co., Ltd., Anhui Zhongshengsuyuan Biotechnology Co., Ltd., China Metrology Science Research
Institute of Standardization, China National Institute of Standardization, China National Accreditation Center for Conformity Assessment, Kunming University of Science and Technology, Hunan Guangxiu High-tech Life Technology Co., Ltd.,
Shanghai Xinchao Biotechnology Co., Ltd., China Medical Biotechnology Association, Zhongshan Hospital Affiliated to Fudan University, Shenzhen BGI Life Sciences Research
Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine.
The main drafters of this document. Zhao Tongbiao, Hao Jie, Zhou Qi, Cao Jiani, Hu Baoyang, Wang Lei, Ma Aijin, Liang Lingmin, Wang Liu, Zhang Yu, Wei Jun,
Yu Junying, Fu Boqiang, Peng Yaojin, Tan Yuanqing, Ma Juan, Wu Jun, Wang Yukai, Li Xiaoyan, Wang Changlin, Zhai Peijun, Na Tao, Li Tianqing, Lin Ge,
Gao Hengjun, Wu Zhaohui, Li Ka, Li Qiyuan, Zhang Xiaoyan, Chen Qubo.
Technical specifications for the management of pluripotent stem cells in biobanks
1 Scope
This document specifies the general technical requirements for the management of human pluripotent stem cells and mouse pluripotent stem cells in biobanks, including general principles, raw materials
Management and technical requirements for the collection and receipt, establishment, recovery and culture, freezing and storage, quality control, distribution and transportation of materials and related data.
This document applies to the management of human pluripotent stem cells and mouse pluripotent stem cells in biobanks.
This document does not apply to the management of biological samples intended for clinical treatment.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 7408 Data elements and exchange format information exchange date and time representation
GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements
GB/T 37864 General requirements for quality and capability of biobanks
GB/T 40364 Basic terminology for human biobanks
ISO 21709 Processes and quality requirements for the establishment, maintenance and characterization of mammalian cell lines for the preservation of biological specimens in biotechnology (Bi-
ISO 24603 General requirements for the preservation of human and mouse pluripotent stem cells in biotechnology biological specimens (Biotechnology-Biobank-
3 Terms and definitions
The terms and definitions defined in GB/T 40364, ISO 21709 and the following apply to this document.
3.1
stem cellsstemcels
A type of cell that is capable of self-renewal and differentiation into one or more functional cell types.
3.2
Pluripotent stem cellspluripotentstemcels
A type of stem cell that can self-renew without restriction in vitro and has the potential to differentiate into cells of the three germ layers.
Examples. Embryonic stem cells, induced pluripotent stem cells.
Note. Human embryonic stem cells are called human embryonic stem cells.
3.3
Collection collection
The process of obtaining biological samples such as tissues and cells from a donor.
[Source. GB/T 40364-2021, 3.20, modified]
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