GB/T 38735-2020Collection and processing of human urine biomaterial (English PDF)
人类尿液样本采集与处理
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
April 28, 2020
Implementation date
November 1, 2020
Scope
GB/T 38735-2020 is the English-translated version of 人类尿液样本采集与处理.
GB/T 38735-2020 is the Chinese standard "Collection and processing of human urine biomaterial". Its scope clause reads: 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.
Its clauses include terms and definitions; general; preparation before collection.
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Document preview — GB/T 38735-2020
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
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 5 Preparation before collection
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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