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GB/T 39767-2021: Management specification for human biomaterial
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| GB/T 39767-2021 | English | 339 |
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Management specification for human biomaterial
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GB/T 39767-2021
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Basic data | Standard ID | GB/T 39767-2021 (GB/T39767-2021) | | Description (Translated English) | Management specification for human biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Word Count Estimation | 18,199 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 39767-2021: Management specification for human biomaterial---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 biomaterial
ICS 07.080
C40
National Standards of People's Republic of China
Human biological sample 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
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Receive 2
5 Store 3
6 Distribution 4
7 Packaging 5
8 Transport 6
9 Deprecated 7
10 Quality Assurance 8
Appendix A (Normative Appendix) Sample storage and transportation conditions 10
Appendix B (informative appendix) Dry ice consumption 11
Appendix C (informative appendix) Classification of medical waste 12
Reference 13
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, Shenzhen Huada Life Sciences Research Institute, Guangzhou University of Traditional Chinese Medicine
Second Affiliated Hospital (Guangdong Provincial Hospital of Traditional Chinese Medicine), Fudan University, First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), China National Conformity Assessment
Home Accreditation Committee, Shanghai Xinchao Biotechnology Co., Ltd., CIMC Cold Cloud (Beijing) Supply Chain Management Co., Ltd., Shanghai No. 1 Maternity and Infant Insurance
Health Hospital, Fudan University Cancer Hospital, Shanghai Fourth People's Hospital Affiliated to Tongji University, Dalian Sixth People's Hospital, National Health
Committee of Science and Technology Research Institute, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Chinese Science
University Cancer Hospital (Zhejiang Cancer Hospital), Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Kunming Children’s Hospital, Qingdao University
A hospital, Shanghai Changzheng Hospital.
The main drafters of this standard. Gao Hengjun, Xu Xun, Chen Qubo, Zhang Xiaoyan, Li Qiyuan, Yang Yajun, Xu Jingman, Ye Qing, Zhai Peijun, Li Junyan,
Lu Xinyi, Sun Jianbo, He Xuheng, Liu Juan, Du Lili, Zhang Kehao, Li Qian, Sun Menghong, Chen Huan, Man Qiuhong, Pu Chunwen, Ma Xu, Gao Huafang, Liu Xin,
Wang Weiye, Kang Xiaonan, Zheng Zhiguo, Sun Jing, Hu Yue, Liu Yanhong, Wang Ren, Wang Bo, Li Li, Xing Shichao, Wang Xueqi.
Human biological sample management regulations
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 article
Pieces. 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℃~8℃, 15℃~25℃, -15℃~-25℃, -20℃~
-30℃ or -40℃~-55℃, 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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