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GB/T 39768-2021: Classification and coding for human biomaterial
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 39768-2021 | English | 559 |
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Classification and coding for human biomaterial
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GB/T 39768-2021
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Basic data | Standard ID | GB/T 39768-2021 (GB/T39768-2021) | | Description (Translated English) | Classification and coding for human biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Word Count Estimation | 30,387 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 39768-2021: Classification and coding for human biomaterial---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.
Classification and coding for human biomaterial
ICS 07.080
C40
National Standards of People's Republic of China
Classification and coding of human biological samples
Released on 2021-03-09
2021-10-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification rules of human biological samples 2
5 Human biological sample coding rules 2
References 24
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed and managed by the National Standardization Technical Committee for Biological Samples (SAC/TC559).
Drafting organizations of this standard. Fudan University, Shanghai National Engineering Research Center for Biochips, Shanghai Xinchao Biotechnology Co., Ltd., National Health
Institute of Science and Technology of the Health Commission, Shanghai Fourth People’s Hospital Affiliated to Tongji University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai
Renji Hospital Affiliated to Haijiao Jiaotong University School of Medicine, Fudan University Affiliated Tumor Hospital, Fudan University Affiliated Zhongshan Hospital, Nanjing University School of Medicine Affiliated
It belongs to Drum Tower Hospital, Oriental Hepatobiliary Surgery Hospital, Shanghai Changzheng Hospital, Hangzhou Baihan Biotechnology Co., Ltd.
The main drafters of this standard. Jin Li, Ma Xu, Gao Hengjun, Yang Yajun, Li Ka, Man Qiuhong, Zhang Xiaoyan, Gao Huafang, Wang Weiye, Zhang Yang,
Xu Jingman, Zhang Kehao, Sun Menghong, Xu Midie, Ye Qing, Kang Xiaonan, Wang Xueqi, Yang Yuan, Ge Meiling.
Classification and coding of human biological samples
1 Scope
This standard specifies the classification and coding rules for human biological samples.
This standard applies to all institutions engaged in the preservation of human biological samples.
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
Human biomaterial
Any substance obtained or derived from the human body, including but not limited to tissue, blood, urine, skin, bone marrow, muscle, hair, secretions and internal
Organs, etc.
3.2
Typeofhumanbiomaterial
According to the common characteristics and morphology of biological samples, the types of biological samples are divided, which can be divided into tissues, blood, semen, secretions,
Cell suspension, excrement, cells or processed biological samples (DNA, RNA, protein, etc.), and other biological materials, etc.
3.3
Whole blood
Collect human peripheral blood into a mixture formed in a blood collection tube/bag with an appropriate amount of anticoagulant.
Note. All blood components including blood cells and plasma.
3.4
General biomaterial
Physical specimens are complete organs or organisms as opposed to sliced samples.
Example. Such as a human brain or embryo sample soaked in formalin.
3.5
Circulating-freecelDNA; cf-DNA
The extracellular DNA present in body fluids such as plasma or serum is referred to as free DNA.
Note. Extracellular DNA is also called circulating DNA or cell-free DNA.
3.6
Circulating tumor DNA; ct-DNA
Necrotic or apoptotic tumor cells with tumor-specific mutations or epigenetic changes, which are contained in free DNA (cf-DNA)
Tumor DNA fragments released into the peripheral blood are referred to as circulating tumor DNA.
Note. Part of cf-DNA in tumor patients.
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