GB/T 37864-2019General requirements of quality and competence for biobank (English PDF)
生物样本库质量和能力通用要求
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
August 30, 2019
Implementation date
August 30, 2019
Scope
GB/T 37864-2019 is the English-translated version of 生物样本库质量和能力通用要求.
GB/T 37864-2019 is the Chinese standard "General requirements of quality and competence for biobank". Its scope clause reads: This standard specifies the general requirements for the capacity, fairness, and continuous operation (including quality control) of biological sample banks to ensure biological samples and numbers.
According to the quality. This standard applies to all institutions engaged in the preservation of biological samples, including the preservation of multicellular organisms (eg humans, animals, etc.) for research and development.
A library of biological samples of fungi and plants) and microorganisms. Biobank users, regulatory agencies, peer assessment organizations, and accredited organizations can use this Standards to confirm or recognize the capabilities of a biological sample bank.
This standard does not apply to biological samples for food, seed production, analysis and treatment. Note 1. International, national and regional regulations or requirements also apply to specific provisions of this standard.
Note 2. Institutions that collect and use human samples for diagnostic and therapeutic purposes first comply with ISO 15189 and other clinical standards. Its clauses include terms and definitions.
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Document preview — GB/T 37864-2019
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- C 40
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General requirements
- 4.1 General
- 4.2 Impartiality
- 4.3 Confidentiality
- 5 Structural requirements
- 6 Resource Requirements
- 6.1 General
- 6.2 Personnel
- 6.3 Infrastructure/Special Site and Environmental Requirements
- 6.4 Externally provided processes, products and services
- 6.5 Equipment
- 7 Process Requirements
- 7.1 General
- 7.2 Collection of biological samples and related data
- 7.3 Receiving and distributing biological samples and related data
- 7.4 Transport of biological samples and related data
- 7.5 Traceability of biological samples and related data
- 7.6 Preparation and preservation of biological samples
- 7.7 Storage of biological samples
- 7.8 Quality control of biological samples and related data
- 7.9 Confirmation and verification of the method
- 7.10 Information and Data Management
- 7.11 does not match output
- 7.12 Reporting requirements
- 7.13 Complaint
- 8 Management requirements
- 8.1 Method
- 8.2 Quality Management System Document Information Record (Method A)
- 8.3 Quality Management System Document Control (Method A)
- 8.4 Record (Method A)
- 8.5 Risk Prevention Measures (Mode A)
- 8.6 Improvements (method A)
- 8.7 Corrective Action (Method A)
- 8.8 Internal Audit (Method A)
- 8.9 Quality Management Review (Method A)
- Appendix A (Normative) Document Requirements
- Appendix B (Informative Appendix) Implementation Guide for Appendix A
- Appendix C (informative) Quality Management System Options
1 Scope
This standard specifies the general requirements for the capacity, fairness, and continuous operation (including quality control) of biological sample banks to ensure biological samples and numbers.
According to the quality.
This standard applies to all institutions engaged in the preservation of biological samples, including the preservation of multicellular organisms (eg humans, animals, etc.) for research and development.
A library of biological samples of fungi and plants) and microorganisms. Biobank users, regulatory agencies, peer assessment organizations, and accredited organizations can use this
Standards to confirm or recognize the capabilities of a biological sample bank.
This standard does not apply to biological samples for food, seed production, analysis and treatment.
Note 1. International, national and regional regulations or requirements also apply to specific provisions of this standard.
Note 2. Institutions that collect and use human samples for diagnostic and therapeutic purposes first comply with ISO 15189 and other clinical standards.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
ISO 8601 data element and exchange format information exchange date and time representation (Dateelementsandinterchange formats-Informationinterchange-Representationofdatesandtimes)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Registration accession/logging
Record new biological samples and/or related data.
3.2 Get acquisition
The act of obtaining ownership and/or regulatory power of the sample and/or related data.
3.3 Related data associateddata
Accessory information for biological samples, including but not limited to research data, phenotypic data, clinical data, epidemiological data, and biological sample processing
The data obtained by the process, etc.
3.4 Sample identification
The process of determining the authenticity of a sample by determining the properties of the biological sample at a certain level by a specific technical means/document.
3.5 Biological sample bank biobank
The legal entity or part of the biological sample collection (3.6).
GB 11417.2 | GB/T 40177 | GB/T 11417.4 | GB/T 47332 | GB 47498.2 | […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 57 pages — is available in the English PDF.
Referenced standards
Cited by
- GB/T 47332-2026Biobanks - Sharing specification for human biological materials and related data
- GB/T 16126-2025Specification for quality assurance of human biomonitoring
- GB/T 45633-2025Collection and processing of human saliva biomaterial
- GB/T 45743-2025Biomaterial - General requirements for transportation of cells
- GB/T 46408-2025Specification on data management and publication in microbial resource centers
- GB/T 43645-2024Ornamental plants—Directives for the construction and conservation of the germplasm resources bank
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