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GBZ44314-2024: Biotechnology - Biobanking - Requirements for the biobanking of animal biological material
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| GB/Z 44314-2024 | English | 554 |
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Biotechnology - Biobanking - Requirements for the biobanking of animal biological material
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GB/Z 44314-2024
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Basic data | Standard ID | GB/Z 44314-2024 (GB/Z44314-2024) | | Description (Translated English) | Biotechnology - Biobanking - Requirements for the biobanking of animal biological material | | Sector / Industry | National Standard | | Classification of Chinese Standard | C04 | | Classification of International Standard | 07.080 | | Word Count Estimation | 28,270 | | Date of Issue | 2024-08-23 | | Date of Implementation | 2024-08-23 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ44314-2024: Biotechnology - Biobanking - Requirements for the biobanking of animal biological material
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GB /Z 44314-2024.Requirements for the storage of biological samples for biotechnology Animal biological samples
Guiding technical documents of the People's Republic of China on national standardization
ICS 07.080CCS C 04
Biotechnology Biospecimen Deposit
Requirements for the preservation of animal biological samples
(ISO /TS 20388.2021, Biotechnology-Biobanking-Requirements for
animal biological material, IDT)
2024-08-23 Release
2024-08-23 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface Ⅲ
Introduction Ⅳ
1 Scope...1
2 Normative references ...1
3 Terms and Definitions 1
4 General requirements 3
4.1 General requirements 3
4.2 Ethical requirements 3
4.3 Health and Safety 4
5 Collection of biological samples 4
5.1 Before Collection...4
5.2 Collection 6
6 Transportation of biological samples and related data 8
7 Receiving...9
8 Preparation and preservation of biological samples 9
9 Storage of biological samples 10
10 Distribution, destruction and disposal of biological specimens 10
10.1 Distribution 10
10.2 Destruction and Disposal 10
11 Information Collection...10
Appendix A (Informative) Animal Biological Sample Data Collection Form (Example) 11
Appendix B (Informative) Collection methods for animals of different natures and sizes 13
B.1 Different animal restraint methods...13
B.2 Solid tissue sample collection example 13
B.3 Examples of blood sample collection methods 13
B.4 Examples of urine sample collection methods 14
B.5 Examples of milk sample collection methods for ruminants and small mammals 14
B.6 Examples of other sample collection methods 15
Appendix C (Informative) Biological Sample Transfer Agreement or other equivalent document information ...16
Appendix D (Normative) Methods for Collection, Preparation and Storage of Biological Samples 17
References ...19
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 for standardization documents"
Drafting is required.
This document is equivalent to ISO /TS 20388.2021 "Requirements for the storage of biological samples from animals for biotechnology biological samples storage".
The type was adjusted from ISO 's technical specifications to my country's national standardization guiding technical documents.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document was proposed and coordinated by the National Technical Committee on Biological Sample Standardization (SAC/TC 559).
This document was drafted by. Shenzhen BGI Life Sciences Institute, Shanghai Xinchao Biotechnology Co., Ltd., Guangdong Provincial Hospital of Traditional Chinese Medicine (Guangzhou
The Second Affiliated Hospital of China Medical University), Institute of Zoology, Chinese Academy of Sciences, Shanghai Biochip Co., Ltd., China National Accreditation Service for Conformity Assessment
Center, Institute of Hydrobiology, Chinese Academy of Sciences, China Food and Fermentation Industry Research Institute Co., Ltd., Beijing Friendship Hospital Affiliated to Capital Medical University
Institute of Zoology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kunming Institute of Zoology, Chinese Academy of Sciences, Fudan University, China Institute of Metrology,
Qingdao MGI Technology Co., Ltd., Shanghai Customs Animal and Plant and Food Inspection and Quarantine Technology Center, Shanghai International Travel Healthcare
Center (Shanghai Customs Port Clinic), Beijing Animal Husbandry Station, Beijing Forestry University, and Zhongshan Hospital Affiliated to Fudan University.
The main drafters of this document are. Xu Xun, Li Qiyuan, Gao Hengjun, Wu Jingjing, Zhang Xiaoyan, Wang Tao, Chen Qubo, Hao Jie, Zhao Tongbiao, Li Junyan,
Wang Xiaolong, Wei Jinpu, Pan Luqian, Wang Bo, Zhang Yun, Kang Xiaonan, Yin Tingting, Yang Yajun, Liu Shanshan, Wang Jing, Wang Mengmeng, Fu Boqiang, Tian Zhenggan,
Lu Ye, Yang Yuze, Zhang Li, Qiao Gexia, Li Jian, Peng Liren, Xu Yanping, Xu Jiliang, Wang Ran, Li Ka, Du Siqi.
Introduction
This document contains requirements and recommendations to enable biobanks that handle animal biospecimens to demonstrate their competence in
operations, and have the capacity to provide animal biospecimens and associated data of appropriate quality for research and development.
This document supports the process of maintaining animal welfare as it is rooted in the three R principles. “Replace, reduce and improve
use”[18].
The use of this document will help ensure the quality of animal biological specimens and the reliability of research results when ISO 20387 is applied.
The following modal verbs may be used in this document.
-- "shall" indicates a requirement;
--“宜” indicates suggestion;
--“可” means permission;
--“能” indicates a possibility or ability.
Biotechnology Biospecimen Deposit
Requirements for the preservation of animal biological samples
1 Scope
This document specifies the procedures for the collection, receipt, preparation, preservation, transport, storage, distribution, destruction and disposal of biological specimens from animals (excluding humans).
Such resources include solid tissue samples, fluids and associated cells, excreta, and related data.
This document applies to biological samples and/or related data used for research and development, and to biological molecules obtained from biological samples, such as nucleic acids,
Proteins and metabolites.
This document is applicable to all organizations conducting research and developing biobanking practices.
This document does not apply to biological samples intended for food or feed production, laboratory research for food or feed production or therapeutic purposes.
Research or a combination of the above.
This document is not intended for use in the establishment of cell lines derived from animal biological specimens.
NOTE. International, national and regional regulations or requirements may also apply to specific clauses in this document.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 37864-2019 General requirements for quality and capability of biobanks (ISO 20387.2018, IDT)
Laboratory biosafety manual (4th edition) by the World Health Organization
zation, 4th edition, 2020)
3 Terms and definitions
The terms and definitions defined in GB/T 37864-2019 and the following apply to this document.
3.1
Animals
A multicellular heterotrophic organism with the ability to sense and move autonomously, whose cells differ from those of most plants in that they have no cell walls.
3.2
associated data
Information accompanying biological samples (3.5), including but not limited to research data, phenotypic data, clinical data, epidemiological data, genetic data,
data, taxonomic data, and data obtained during biological sample processing, etc.
[Source. GB/T 37864-2019, 3.3, modified]
3.3
Biobank
The legal entity or part thereof that carries out the deposit of biological specimens (3.4).
[Source. GB/T 37864-2019, 3.5]
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