GB/T 40364-2021 English PDF

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GB/T 40364-2021: Fundamental terminology for human biobank
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Basic data

Standard ID: GB/T 40364-2021 (GB/T40364-2021)
Description (Translated English): Fundamental terminology for human biobank
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C40
Word Count Estimation: 14,122
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 40364-2021: Fundamental terminology for human biobank

---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.
Fundamental terminology for human biobank ICS 07.080 CCSC40 National Standards of People's Republic of China Basic terminology of human biobank 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 Reference 5 Index 6

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 is under the jurisdiction of the National Standardization Technical Committee for Biological Samples (SAC/TC559). Drafting organizations of this document. Fudan University, Shanghai Xinchao Biotechnology Co., Ltd., Shanghai National Engineering Research Center for Biochips, National Health Institute of Science and Technology of the Health Commission, Shanghai Fourth People's Hospital Affiliated to Tongji University, Zhongshan Hospital Affiliated to Fudan University, Shanghai Jiaotong University Xinhua Hospital Affiliated to School of Medicine, Tumor Hospital Affiliated to Fudan University, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Changzheng Hospital, Navy The Third Affiliated Hospital of Military Medical University, Shanghai Medical Clinical Research Center Co., Ltd., Shenzhen BGI Institute of Life Sciences, Shanghai International Human Table Type Group Research Institute. The main drafters of this document. Jin Li, Gao Hengjun, Ma Xu, Yang Yajun, Zhang Xiaoyan, Xu Jingman, Gao Huafang, Man Qiuhong, Li Ka, Wang Weiye, Sun Menghong, Kang Xiaonan, Wang Xueqi, Yang Yuan, Ruan Liangliang, Li Qiyuan, Zhang Yang, Guo Yunfeng, Xu Midie, Chen Xingdong, Yuan Ziyu.

Introduction

The series of standards for human biobanks provides a model and requirements that can be followed for the establishment and operation of human biobanks and their management systems. It is composed of multiple standards related to the construction of human biological sample bank. This document is the basic terminology. By using the human biological sample bank to define basic terms, it is conducive to the establishment of human biological sample bank and the management of human biological samples. Basic terminology of human biobank

1 Scope

This document defines the basic terms and definitions of the human biological sample bank. This document is applicable to all institutions engaged in the preservation of human biological samples.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

3.1 Quantitative quantitation A description of the physical characteristics of a human biological sample. 3.2 Sample type typeofbiologicalmaterial Classify biological samples based on their biological characteristics. Note 1.Named after information with scientific meaning, does not contain the names of specific human organs and organ parts. Types of biological samples can include collected The original material form, including but not limited to whole blood, urine, serum, plasma, semen, cells, etc.; or the material form processed by technical methods, including but not limited to Not limited to DNA, RNA, protein, etc. Note 2.Human biological samples can be divided into tissues, blood, body fluids, semen, secretions, cell suspensions, excreta, cells or processed biological samples according to their nature. Material samples (DNA, RNA, protein, etc.), and others. 3.3 Biobank manager biobankmanager One or more persons who have the ability to be responsible for the biological sample bank and have the authority to manage. 3.4 Infectious biological material Biological samples containing or suspected of containing pathogens. 3.5 Preanalyticalphase The process that the sample goes through before analysis. Note. According to the chronological order, including collecting samples, transporting to the laboratory and transporting in the laboratory, separating the analyte, and ending when the analytical inspection begins. 3.6 Donor A person or organization that provides biological samples and/or related data to the biological sample bank. Note. Does not include proficiency testing providers and external suppliers. [Source. GB/T 37864-2019, 3.41, with modification] 3.7 Voluntary freewil After the donor or his legal guardian fully understands the information related to the research, it is not affected by any external factors or external pressure. ......

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