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GB/T 45633-2025: Collection and processing of human saliva biomaterial
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Collection and processing of human saliva biomaterial
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GB/T 45633-2025
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Basic data | Standard ID | GB/T 45633-2025 (GB/T45633-2025) | | Description (Translated English) | Collection and processing of human saliva biomaterial | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C04 | | Classification of International Standard | 07.080 | | Word Count Estimation | 14,116 | | Date of Issue | 2025-04-25 | | Date of Implementation | 2025-04-25 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 45633-2025: Collection and processing of human saliva 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.
ICS 07.080
CCSC04
National Standard of the People's Republic of China
Human saliva sample collection and processing
Released on 2025-04-25
2025-04-25 implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Basic Requirements 2
5 Preparation before sampling 2
6 Saliva sample collection 3
7 Saliva sample processing 4
8 Saliva sample data collection 5
Appendix A (Informative) Saliva Sample Collection Equipment and Recommended Sample Volume 6
Appendix B (Informative) Saliva Sample Contents and Applicable Scope 7
Appendix C (Informative) Suggested Contents of Saliva Sample Dataset 8
References 9
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document was proposed and coordinated by the National Technical Committee on Biological Sample Standardization (SAC/TC559).
This document was drafted by. Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Peking University Stomatological Hospital, Capital Medical University
Beijing Stomatological Hospital, Shanghai Xinchao Biotechnology Co., Ltd., West China Hospital of Stomatology, Sichuan University, PLA Air Force Medical University
Third Affiliated Hospital, Affiliated Stomatological Hospital of Chongqing Medical University, Fudan University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine), Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Cancer Hospital Affiliated to Fudan University, Shanghai Guo
International Human Phenotype Group Research Institute, Stomatological Hospital of Sun Yat-sen University, Cancer Center of Sun Yat-sen University, Huashan Hospital of Fudan University, Wuhan University
Shanghai University of Stomatology Hospital, Shanghai Yikang Medical Laboratory Co., Ltd., and Shanghai Clinical Research Center.
The main drafters of this document are. Li Jiang, Zhang Zhiyuan, Xu Feng, Wang Xueling, Chen Yueyao, Shi Huan, Zhang Qianqian, Hua Hong, Zheng Shuguo, Jin Luyuan, Jiang Lu,
Zhang Xiaoyan, Shen Xuemin, Su Jiazeng, Lu Haixia, Niu Lina, Song Jinlin, Yang Yajun, Wang Weiye, Chen Qubo, Kang Xiaonan, Sun Menghong, Xu Midie,
Guo Yunfeng, Xia Juan, Zheng Xiaohui, Zhong Laiping, Jia Weihua, Zhou Gang, He Yue, Jiang Yueming, Liang Wei.
Introduction
Human saliva is a physiological substance secreted by the salivary glands. It contains rich biological information and can reflect the state of the human body to a certain extent.
The relevant markers in human saliva samples are of great significance in disease detection. The collection of human saliva samples is simple, non-invasive,
The technology has the advantages of low sensitivity, low cost, high efficiency, no restrictions on time and place, and easy acceptance by saliva sample providers.
Many scientific research units and large medical institutions in my country need to collect human saliva samples for clinical and basic research.
There is currently no relevant national standard to regulate the collection and processing of saliva samples for various purposes.
This will result in uneven quality of saliva samples, making them unusable for subsequent research, causing serious waste of resources and affecting resource sharing.
Developing unified and standardized saliva sample collection and processing can identify and eliminate potential variability factors in the process, thereby improving the quality of saliva samples.
The quality of this research is beneficial to improving the consistency of the later research process and the reliability and accuracy of experimental data, which is of great significance to promoting the progress of scientific research and
Optimization of clinical practice has far-reaching significance and value.
Human saliva sample collection and processing
1 Scope
This document specifies the general requirements for the collection and processing of human saliva samples, describing the pre-collection preparation, saliva sample collection, saliva sample
Methods of processing and information collection of saliva samples.
This document applies to the collection and processing of human saliva samples for clinical and basic medical research involved in biobanks.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 37864-2019 General requirements for quality and capability of biobanks
GB/T 38736 Ethical requirements for the preservation of human biological samples
GB/T 43429 General requirements for the preservation of pathogenic microorganisms and samples of human infections
WS/T 313 Specification for Hand Hygiene of Medical Staff
3 Terms and definitions
The terms and definitions defined in GB/T 37864-2019 and the following apply to this document.
3.1
Saliva
A hypotonic fluid secreted by the salivary glands.
Note. It is the mixed secretion of the parotid gland, submandibular gland, sublingual gland and various minor salivary glands, mainly composed of water, electrolytes and proteins.
3.2
Wholesaliva
Mixed saliva is the sum of all the fluids that may collect in the mouth.
Note. Includes saliva, gingival crevicular fluid, oral microbiota and its metabolites, mucosal cell fragments, nasal secretions and food residues.
3.3
parotid saliva
Saliva secreted by the parotid glands and carried to the mouth via the parotid ducts.
3.4
Saliva is secreted by the submandibular gland and sublingual gland and transported to the oral cavity from the submandibular gland duct.
Note. The sublingual gland duct flows into the submandibular gland duct. The saliva collected by the submandibular gland duct orifice includes the saliva of the submandibular gland and the sublingual gland.
3.5
Saliva is secreted by various small salivary glands in the oral cavity (such as lip glands, palatine glands, etc.) and transported to the oral cavity through the openings of the mucosal ducts in the area.
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