US$409.00 · In stock Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 39766-2021: Management specification for human biobank Status: Valid
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
GB/T 39766-2021 | English | 409 |
Add to Cart
|
4 days [Need to translate]
|
Management specification for human biobank
| Valid |
GB/T 39766-2021
|
PDF Samples
Basic data Standard ID | GB/T 39766-2021 (GB/T39766-2021) | Description (Translated English) | | Sector / Industry | National Standard (Recommended) |
GB/T 39766-2021: Management specification for human biobank---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Management specification for human biobank
ICS 07.080
C40
National Standards of People's Republic of China
Human Biobank Management Regulations
Released on 2021-03-09
2021-10-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General 2
5 Organizational structure 2
6 people 3
7 Facilities and environment 4
8 Equipment 6
9 Reagents and consumables 8
10 Information System 8
Appendix A (Normative Appendix) Functional Zone 12
Appendix B (informative appendix) Equipment 14
Appendix C (informative appendix) Reagents and consumables 16
Reference 17
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed and managed by the National Standardization Technical Committee for Biological Samples (SAC/TC559).
Drafting organizations of this standard. Shanghai National Engineering Research Center for Biochips, Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Traditional Chinese Medicine)
Hospital), Shanghai Xinchao Biotechnology Co., Ltd., Affiliated Tumor Hospital of University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Fudan University, China
National Accreditation Committee for Qualifications, Shanghai Tangyi Information Technology Co., Ltd., Qingdao Haier Biomedical Co., Ltd., Wuxi Langjiatong
Creative Software Co., Ltd., Shenzhen BGI Institute of Life Sciences, Shanghai Medical Clinical Research Center, Xinhua Medical, affiliated to Shanghai Jiaotong University School of Medicine
Hospital, Zhongshan Hospital Affiliated to Fudan University, First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Shanghai Jiaotong University School of Medicine Affiliated Ren
Ji Hospital, Fudan University Affiliated Tumor Hospital, National Health Commission Institute of Science and Technology, Chinese Academy of Medical Sciences Peking Union Medical College Hospital.
The main drafters of this standard. Gao Hengjun, Chen Qubo, Zhang Xiaoyan, Xu Jingman, Du Lili, Zheng Zhiguo, Yang Yajun, Liu Lei, Zhai Peijun,
Li Junyan, Lu Xinyi, Tang Wan, Liu Zhanjie, Feng Min, Gu Yinxiao, Zhang Kehao, Xu Xun, Li Qiyuan, Ruan Liangliang, Wang Chuyang, Wang Weiye, Li Ka, Ye Qing,
Sun Jianbo, He Xuheng, Hong Junkai, Kang Xiaonan, Sun Menghong, Chen Huan, Ma Xu, Gao Huafang, Liu Xin, Guo Dan, Wang Feng.
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")
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 article
Pieces. 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.
3.1
Human biobank
A legal entity or part of it that carries out the preservation of human biological samples.
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.
......
|