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GB/T 38735-2020: Collection and processing of human urine biomaterial
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 38735-2020 | English | 189 |
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Collection and processing of human urine biomaterial
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GB/T 38735-2020
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Basic data | Standard ID | GB/T 38735-2020 (GB/T38735-2020) | | Description (Translated English) | Collection and processing of human urine biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 07.080 | | Word Count Estimation | 10,117 | | Date of Issue | 2020-04-28 | | Date of Implementation | 2020-11-01 | | Quoted Standard | GB/T 37864-2019; WS/T 348-2011 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard specifies the general rules for the collection and processing of human urine samples, preparation before collection, sample information recording, urine collection, and urine processing. This standard applies to the collection and processing of human urine samples involving clinical research, basic research and the construction of biobanks. | GB/T 38735-2020: Collection and processing of human urine 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.
Collection and processing of human urine biomaterial
ICS 07.080
C40
National Standards of People's Republic of China
Human urine sample collection and processing
2020-04-28 release
2020-11-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
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 Biological Sample Standardization Technical Committee (SAC/TC559).
This standard was drafted by. Shenzhen Huada Life Science Research Institute, Biochip Shanghai National Engineering Research Center, Beijing Normal University, Shanghai
Municipal Endocrine and Metabolic Diseases Research Institute, Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Shanghai Oriental Hospital (Tongji University Affiliated Oriental Hospital),
Eastern Theater General Hospital, the First Affiliated Hospital of Gannan Medical College, Shanghai Xinchao Biological Technology Co., Ltd., Zhejiang Cancer Hospital, Fudan University,
Renji Hospital, Shanghai Jiaotong University School of Medicine.
The main drafters of this standard. Xu Xun, Gao Hengjun, Li Qiyuan, Gao Youhe, Zhang Xiaoyan, He Xuheng, Xu Jingman, Dai Meng, Chen Qubo, Sun Jianbo,
Wang Congrong, Zheng Chunxia, Tang Rong, Liu Zhihong, Kang Xiaonan, Yang Yajun, Zheng Zhiguo, Guo You, Wang Ren, Wang Bo.
Introduction
Urine samples are rich in biological information such as proteomics, genomics, transcriptomics, microbiome and metabolomics.
It reflects the functional state of the urinary system and can reflect the pathophysiological state of the body. Urinary components change early in the course of disease development
It is an ideal biological sample for screening and early diagnosis, and can be used for many aspects of human disease prevention, diagnosis, treatment and prognosis monitoring.
Research and clinical applications provide more reference information. More importantly, urine collection is non-invasive, simple and convenient, and donor compliance
Advanced features.
Many scientific research units and large medical institutions in my country collect urine samples for clinical and basic research. However, for urine samples for scientific research
At present, there is no relevant national standard to regulate the collection and processing process. The quality of urine collection is uneven and cannot even be used in subsequent studies,
It causes a serious waste of resources and also affects the sharing of resources.
The standardization of urine sample collection and processing can provide high-quality urine samples for clinical and basic research, translational medical research, etc.
Promote the full use of urine sample resources. In addition, standardized operating procedures provide a unified standard for future urine sample sharing, which
The development of quasi-medicine is of great significance.
Human urine sample collection and processing
1 Scope
This standard specifies the general principles of human urine sample collection and processing, preparation before collection, sample information recording, urine collection, and urine processing.
This standard is applicable to the collection and processing of human urine samples related to clinical research, basic research, and fields related to the construction of biological samples.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 37864-2019 General requirements for the quality and capability of biological sample banks
WS/T 348-2011 Guidelines for collection and treatment of urine specimens
3 Terms and definitions
The terms and definitions defined in GB/T 37864-2019 apply to this document.
4 General
4.1 Donor selection criteria should be formulated according to the development of the subject or the needs of the subject, based on the expected use of biological samples, mature technology or related standards
Wait to determine the urine sample collection and processing plan, formulate a reasonable work flow, and clarify the responsibilities of the relevant personnel.
4.2 The collection plan should be approved by the ethics committee.
4.3 Before collection, the donor should be informed in advance of the purpose, use, possible impact on health, personal privacy protection measures and their enjoyment
The right to participate voluntarily and withdraw unconditionally at any time is subject to written consent. When informing the donor of the information specified in the preceding paragraph, it should be comprehensive, complete,
It is true and accurate, and must not be concealed, misled or deceived.
5 Preparation before collection
5.1 Sample information mark
5.1.1 Sample preparation, collection/collection, acquisition and reception, recording, registration, cataloging/classification, inspection, preparation, preservation, storage, number
According to the whole process of management, destruction, packaging and security protection, distribution and transportation, it should be clearly and clearly marked to ensure that the sample has a unique identification
Symbols and traceability.
5.1.2 Prior to collection, the informed consent, urine retention container, and dispensing container should be uniquely identified, and should not be marked on the container lid.
5.1.3 It should be ensured that the content of the logo is clear and recognizable, and characters cannot overlap.
5.1.4 The printed materials and adhesive materials used for the logo should be resistant to low temperatures and can be used in various storage environments, especially in dry ice and liquid nitrogen environments.
Frequent use, not easily affected by water and chemical reagents, etc., to ensure that it does not fall off or damage during transportation and storage.
5.1.5 It is advisable to adopt methods such as printing labels, bar codes, two-dimensional codes, radio frequency identification technology (RFID), microelectronic mechanical systems (MEMS), etc.
Avoid misinterpretation of the logo caused by handwriting.
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