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GB/T 39768-2021Classification and coding for human biomaterial (English PDF)

人类生物样本分类与编码

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 9, 2021

Implementation date

October 1, 2021

Scope

GB/T 39768-2021 is the English-translated version of 人类生物样本分类与编码.

GB/T 39768-2021 fixes the classification and coding of human biological samples. It sets the classes into which the samples are divided and the rules by which each of them is coded, so that a sample can be identified and traced across the institutions that hold it.

It applies to every institution that preserves human biological samples. Biobanks, hospitals and research institutes use it. Issued on 9 March 2021, it has applied since 1 October 2021.

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Document preview — GB/T 39768-2021

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
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Classification rules of human biological samples
  • 5 Human biological sample coding rules

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

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