GB/T 39767-2021Management specification for human biomaterial (English PDF)
人类生物样本管理规范
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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 39767-2021 is the English-translated version of 人类生物样本管理规范.
GB/T 39767-2021 is the Chinese management specification for human biological samples. It sets the requirements for receiving a sample, storing it, managing it, distributing it, packing it, transporting it, discarding it and for the quality assurance that covers the whole chain.
It applies to the institutions that run human biobanks. Hospitals, research institutes and accreditation bodies use it, with the management of the bank itself covered by GB/T 39766-2021. Issued on 9 March 2021, it has applied since 1 October 2021.
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Document preview — GB/T 39767-2021
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 Receive
- 5 Store
- 6 Distribution
- 7 Packaging
- 8 Transport
- 9 Deprecated
- 10 Quality Assurance
- Appendix A (Normative Appendix) Sample storage and transportation conditions
- Appendix B (informative appendix) Dry ice consumption
- Appendix C (informative appendix) Classification of medical waste
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the reception, storage, management, distribution, packaging, transportation, discarding, and quality assurance of human biological samples (hereinafter referred to as "samples") Sample management requirements such as certificates.
This standard applies to institutions engaged in the management of human biological sample banks.
This standard does not apply to the management of biological samples in the diagnosis and treatment activities of medical institutions.
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 5458-2012 Liquid nitrogen biological container
GB/T 37864-2019 General Requirements for the Quality and Capability of Biological Repositories
MH/T 1019-2005 Civil Aviation Dangerous Goods Transport Document
3 Terms and definitions
The following terms and definitions defined in GB/T 37864-2019 apply to this document. For ease of use, the following is repeated Certain terms and definitions in GB/T 37864-2019.
3.1 Phase change cold storage bag/board phasechangmaterialbag/panel
According to different phase transition points, it is used to keep the sample temperature at 2°C~8°C, 15°C~25°C, -15°C~-25°C, -20°C~ -30°C or -40°C~-55°C, it is a bag or plate package made of phase change cold storage material.
3.2 Evaluate
According to a certain standard, the process of making description and judgment in the designated task.
3.3 Medicalwaste
Medical and health institutions or institutions engaged in the preservation of human biological samples are generated during medical treatment, prevention, health care, scientific research and other related activities The waste material with direct or indirect infectiousness, toxicity and other hazards.
3.4 Infectious sample
Substances containing active microorganisms that are known or reasonably believed to have an impact on the health and living environment of animals or humans.
3.5 Quality analysis; QC
Technical operating system to determine the standard to evaluate the quality and performance of a program or project, and to verify whether the specified requirements are met.
3.6 Pseudonymization
A method of processing personal data that makes it impossible to identify a specific subject without the use of additional information.
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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.
Referenced standards
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Related Standards
GB/T 37864-2019 — General requirements of quality and competence for biobank
GB/T 5458-2012 — Liquid nitrogen biological container
GB/T 7251.4-2026 — Low-voltage switchgear and controlgear assemblies - Part 4: Particular requirements for assemblies for construction sites (ACS)
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