GB/T 39766-2021Management specification for human biobank (English PDF)
人类生物样本库管理规范
This is a limited preview
Buy now to download the full PDF (21 pages)
Need quotation for your management?
Get a formal quotation for GB/T 39766-2021 in 30 minutes.
Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
March 9, 2021
Implementation date
October 1, 2021
Scope
GB/T 39766-2021 is the English-translated version of 人类生物样本库管理规范.
GB/T 39766-2021 is the Chinese management specification for a human biobank. It sets the requirements on the organisational structure, on the personnel, on the facilities, on the equipment, on the reagents and consumables and on the information system of the bank.
It applies to the institutions that run human biobanks, the collections on which medical research depends. Hospitals, research institutes and the bodies that accredit a biobank use it. Issued on 9 March 2021, it has applied since 1 October 2021.
Found what you need?
Document preview — GB/T 39766-2021
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 Organizational structure
- 6 people
- 7 Facilities and environment
- 8 Equipment
- 9 Reagents and consumables
- 10 Information System
- Appendix A (Normative Appendix) Functional Zone
- Appendix B (informative appendix) Equipment
- Appendix C (informative appendix) Reagents and consumables
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
Human biological samples are an important bridge between clinical disease and basic translational medicine research, and a non-renewable resource for precision medicine research.
The biological sample bank is the executive agency for standardized and standardized collection and processing, preservation management, and transportation and distribution of biological samples and related information resources.
A good organizational structure, personnel, facilities, equipment, consumables and information systems are to ensure the stable operation and sustainable and healthy development of the biological sample library Core foundation. Human Biobank Management Regulations
1 Scope
This standard specifies the organizational structure, personnel, facilities, equipment, reagents and consumables and information of the human biological sample bank (hereinafter referred to as the "sample bank") A legal entity or part of it that carries out the preservation of human biological samples.
The management requirements of biological sample libraries such as chemical systems.
This standard applies to institutions engaged in the management of human biological sample banks.
The human biological sample bank in this standard is used to carry out scientific research activities, and the preservation of sperm, eggs, gametes, and embryos shall not be carried out to the public.
Made. The human biological sample bank shall strictly implement the relevant laws, regulations and regulations on the management of human genetic resources.
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 13690-2009 General Rules for Classification and Hazard Publicity of Chemicals
GB 15630-1995 Fire safety signs setting requirements
GB/T 18883-2002 Indoor Air Quality Standard
GB 19489-2008 General requirements for laboratory biosafety
GB/T 31540.4-2015 Fire Safety Engineering Guide Part 4: Detection, Start and Extinguishment
GB/T 37864-2019 General Requirements for the Quality and Capability of Biological Repositories
GB/T 38736-2020 Ethical requirements for the preservation of human biological samples
GB 50015-2019 Building Water Supply and Drainage Design Standard
GB 50052-2009 Code for Design of Power Supply and Distribution System
3 Terms and definitions
The following terms and definitions defined in GB/T 37864-2019 apply to this document.
3.2 Maternalorganization
The organization to which the public relations agency depends.
3.3 Humanbiobankmanagement
A person or group of persons who command and control an organization at the highest level of the human biobank.
3.4 Aptitude
The conditions, qualifications, abilities, etc. possessed to engage in a certain job or activity.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 13690-2009General rule for classification and hazard communication of chemicals
- GB 15630-1995Requirements for the placement of fire safety signs
- GB/T 18883-2002Standards for indoor air quality
- GB 19489-2008Laboratories - General requirements for biosafety
- GB/T 31540.4-2015Fire safety engineering guide -- Part 4: Detection, activation and suppression
- GB/T 37864-2019General requirements of quality and competence for biobank
Similar standards
How to Download GB/T 39766-2021
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB 13690-2009 — General rule for classification and hazard communication of chemicals
GB 15630-1995 — Requirements for the placement of fire safety signs
GB 19489-2008 — Laboratories - General requirements for biosafety
Secure payment via Stripe
Payments accepted
GB/T 39766-2021
$300.00