GB/T 40352.1-2021Collection and processing of human tissue biomaterial—Part 1:Surgical removal tissue biomaterial (English PDF)
人类组织样本采集与处理 第1部分：手术切除组织
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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 40352.1-2021 is the English-translated version of 人类组织样本采集与处理 第1部分：手术切除组织.
GB/T 40352.1-2021 is the first part of the Chinese national series on collecting and processing human tissue samples, and it deals with tissue removed during surgery.
It sets the basic requirements for these samples through general provisions, preparation before collection, sample collection and sample processing, with an informative annex on pre-analytical variables.
It defines the terms it uses, including fresh, frozen and paraffin tissue biomaterial and warm and cold ischemic time. It applies to biobanks and to the institutions that collect, process or preserve surgically resected human tissue for basic, clinical and translational research, but not to tissue collected for clinical diagnosis and treatment. The standard was issued on 20 August 2021 and has applied since 1 March 2022.
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Document preview — GB/T 40352.1-2021
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
- 4 General
- 5 Preparation before collection
- 6 Sample collection
- 7 Sample processing
- Appendix A (informative appendix) Variables before sample analysis
- Reference
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.
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.
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 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 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 biomaterial
With or without cryoprotectant, store tissue samples below -80°C.
3.4 Paraffin tissue biomaterial
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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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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