GB/T 39767-2021 English PDF

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GB/T 39767-2021: Management specification for human biomaterial
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 39767-2021	339	Add to Cart	4 days	Management specification for human biomaterial	Valid

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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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