GB/T 40364-2021Fundamental terminology for human biobank (English PDF)
人类生物样本库基础术语
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 20, 2021
Implementation date
March 1, 2022
Scope
GB/T 40364-2021 is the English-translated version of 人类生物样本库基础术语.
GB/T 40364-2021 defines the basic terms used for human biobanks, which collect, preserve and manage human biological samples. It belongs to a series of standards on setting up and running human biobanks and their management systems, and applies to all institutions that preserve human biological samples.
Some terms concern the samples themselves, such as quantitation, sample type and infectious biological material, with notes listing sample types from whole blood, serum and plasma to DNA, RNA and protein.
Others deal with the people and stages involved, including the biobank manager, the donor, the pre-analytical phase and voluntary participation. The document has no normative references. It was issued on 20 August 2021 and has applied since 1 March 2022.
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Document preview — GB/T 40364-2021
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- C 40
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
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.
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.
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 Quantitation
A description of the physical characteristics of a human biological sample.
3.2 Sample type
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
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 Preanalytical phase
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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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