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GB/T 40352.1-2021: Collection and processing of human tissue biomaterial - Part 1: Surgical removal tissue biomaterial
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Collection and processing of human tissue biomaterial - Part 1: Surgical removal tissue biomaterial
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GB/T 40352.1-2021
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Basic data | Standard ID | GB/T 40352.1-2021 (GB/T40352.1-2021) | | Description (Translated English) | Collection and processing of human tissue biomaterial - Part 1: Surgical removal tissue biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Word Count Estimation | 14,164 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 40352.1-2021: Collection and processing of human tissue biomaterial - Part 1: Surgical removal tissue biomaterial
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Collection and processing of human tissue biomaterial - Part 1.Surgical removal tissue biomaterial
ICS 07.080
C40
National Standards of People's Republic of China
Human tissue sample collection and processing
Part 1.Surgical removal of tissue
Released on 2021-08-20
2022-03-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General 2
5 Preparation before collection 2
6 Sample collection 3
7 Sample processing 3
Appendix A (informative appendix) Variables before sample analysis 5
Reference 9
Foreword
GB/T 40352 "Human Tissue Sample Collection and Processing" is intended to consist of the following parts.
---Part 1.Surgical removal of tissue;
---Part 2.Biopsy tissue;
---Part 3.Autopsy tissue.
This part is Part 1 of GB/T 40352.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part was proposed and managed by the National Standardization Technical Committee for Biological Samples (SAC/TC559).
Drafting organizations of this section. Shanghai National Engineering Research Center for Biochips, Zhejiang Cancer Hospital, Nanjing Gulou Hospital, Taizhou Medical Center, Zhejiang Province
Hospital, the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine), Fudan University Affiliated Cancer Hospital, Tianjin Medical University Affiliated Cancer Hospital
Hospital, Sun Yat-sen University Cancer Center, Shanghai Xinchao Biotechnology Co., Ltd., Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.
The main drafters of this section. Gao Hengjun, Zheng Zhiguo, Zhang Xiaoyan, Ye Qing, Lin Aifen, Chen Qubo, Xu Jingman, Xu Midie, Sun Menghong, Li Haixin,
Hu Yue, Kang Xiaonan, Sun Wei, Shi Jingjing, Yan Weihua, Jia Weihua, Zheng Xiaohui, Lu Xinyi, Wu Weilin.
Introduction
Surgical removal of tissue samples is an important bridge for human disease basic, clinical and translational medicine research, and it is a non-renewable precision medicine research.
Sexual resources are also important resources in the fields of drug target discovery, new drug development and biomarker research and development. Establish surgical resection tissue sample collection
Collection and processing technical requirements to ensure the standardized collection and processing of surgical resection tissue samples are the basis for establishing a high-quality human tissue sample library
And key.
Human tissue samples are mainly divided into surgical resection tissue, biopsy tissue and autopsy tissue according to the source of acquisition.
Human tissue sample collection and processing
Part 1.Surgical removal of tissue
1 Scope
This part of GB/T 40352 specifies the basic requirements for the collection and processing of human surgically resected tissue samples.
This part is applicable to basic, clinical and translational medicine research and the collection and collection of tissue samples involving human surgical resection in biological sample banks.
Processing, and all institutions engaged in the preservation of human tissue samples.
This section does not apply to the collection and processing of tissue samples for clinical diagnosis and treatment.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 37864-2019 General Requirements for the Quality and Capability of Biological Repositories
3 Terms and definitions
The following terms and definitions defined in GB/T 37864-2019 apply to this document.
3.1
Tissue biomaterial
Human body tissue collected by professionals.
Note. Such as human tumors and other focal tissues and their control tissues.
3.2
Fresh tissue biomaterial
An in vitro tissue sample without any other treatments obtained by a professional in accordance with a standardized sampling procedure within a specified time.
3.3
Frozen tissue frozenissuebiomaterial
With or without cryoprotectant, store tissue samples below -80℃.
3.4
Paraffintissuebiomaterial
Fresh tissue samples are chemically fixed (such as neutral formalin fixative), and then subjected to standardized dehydration, transparency, and wax immersion
And embedding and other procedures, the prepared samples.
3.5
Warm ischemic time
The period from when the blood supply to human organs or tissues ceases to when they leave the human body.
3.6
Cold ischemic time
The period from when the organ or tissue leaves the human body to when it is processed.
Note. The treatment includes adding a fixed solution or aliquoting into a cryotube (with or without stabilizing solution, etc.) for cryopreservation, etc.
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