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GB/T 46302-2025 English PDF

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GB/T 46302-2025: Automatic sample processing system for medical use
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB/T 46302-2025	English	439	Add to Cart	4 days [Need to translate]	Automatic sample processing system for medical use	Valid	GB/T 46302-2025

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Basic data

Standard ID	GB/T 46302-2025 (GB/T46302-2025)
Description (Translated English)	Automatic sample processing system for medical use
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100.10
Word Count Estimation	22,27
Date of Issue	2025-10-05
Date of Implementation	2026-11-01
Issuing agency(ies)	State Administration for Market Regulation and Standardization Administration of China

GB/T 46302-2025: Automatic sample processing system for medical use

---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 11.100.10 CCSC44 National Standards of the People's Republic of China Fully Automated Medical Sample Processing System Published on 2025-10-05 Implemented on 2026-11-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4.General Requirements 1 5 Requirements 2 5.1 Sample Input Module 2 5.2 Centrifuge Module 2 5.3 Removal Module 4 5.4 Sample Scoring Module 4 5.5 Track Module 5 5.6 Interface Module 5 5.7 Cover Module 5 5.8 Sample Output Module 5 5.9 Sample Storage Module 6 5.10 Software Module 6 5.11 Overall System Performance 7 5.12 Appearance 7 5.13 Electrical safety requirements 8 5.14 Electromagnetic compatibility requirements 8 5.15 Environmental Testing 8 6.Test Methods 8. 6.1 Normal working conditions 8 6.2 Sample Input Module 8 6.3 Centrifuge Module 8 6.4 Removal Module 10 6.5 Sample Tube Dispensing Module 11 6.6 Track Module 12 6.7 Interface Module 12 6.8 Cover Module 12 6.9 Sample Output Module 13 6.10 Sample Storage Module 13 6.11 Software Module 14 6.12 Overall system performance. 14 6.13 Appearance 14 6.14 Electrical Safety Requirements 14 6.15 Electromagnetic compatibility requirements 15 6.16 Environmental Testing 15 7.Labels, markings, and instructions for use 15 8 Packaging, transportation and storage 15 8.1 Packaging 15 8.2 Transportation 15 8.3 Storage 15 References 16

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Beijing Institute for Medical Device Testing (Beijing Medical Biological Protective Equipment Testing and Research Center), China Food... Drug Testing Institute, Jiangsu Provincial Medical Device Testing Institute, Beijing Tiantan Hospital affiliated to Capital Medical University, Shenzhen Yahuilong Biotechnology Co., Ltd. Limited Liability Company, Shandong Boke Biotechnology Industry Co., Ltd., Hitachi Diagnostics Products (Shanghai) Co., Ltd., The Second Affiliated Hospital of Zhejiang University School of Medicine Institute, Antu Laboratory Instruments (Zhengzhou) Co., Ltd., Beijing BGI Genomics Co., Ltd., Dirui Medical Technology Co., Ltd. Mike Medical Electronics Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Beckman Coulter Trading (China) Co., Ltd., Siemens Medical Center Disconnect Products (Shanghai) Co., Ltd., Roche Diagnostics Products (Shanghai) Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen New Industries Biomedical Engineering Co., Ltd. and Changsha Maidec Intelligent Technology Co., Ltd. The main drafters of this document are. Zhao Bingfeng, Wang Yue, Zhou Qiyang, Zhang Guojun, Xiao Yujin, Xie Qinghua, Cheng Qing, Tao Zhihua, Liu Cong, and Cui Xianghua. Huo Ran, Wang Yuanyuan, Wu Xiaojun, Zhou Jing, Wang Kai, Wang Rongfei, Li Xuerong, Yin Li, Song Renjun, Li Shengmin, Sun Li. Fully Automated Medical Sample Processing System

1 Scope

This document specifies the requirements, labeling, instructions for use, packaging, storage, and transportation of fully automated medical sample processing systems, and describes... The corresponding experimental methods. This document applies to clinical samples that are connected to medical testing modules using automated track and information network technologies before and after testing. Processing system. This document does not apply to equipment in clinical laboratory analytical instruments that have precise reagent and sample dispensing functions before analysis.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 191 Pictorial Symbols for Packaging and Storage GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measuring, control and laboratory use – Part 1.General requirements GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments GB/T 42125.1 Safety requirements for electrical equipment for measuring, control and laboratory use - Part 1.General requirements GB/T 42125.5 Safety requirements for electrical equipment for measuring, controlling and laboratory use - Part 5.Special requirements for laboratory centrifuges Require GB/T 42125.14 Safety requirements for electrical equipment for measuring, controlling and laboratory use – Part 14.Laboratory analytical and other applications Special requirements for automatic and semi-automatic equipment YY/T 0086-2020 Medical Refrigerator YY/T 0657-2017 Medical Centrifuges

3 Terms and Definitions

This document does not contain any terms or definitions that need to be defined. 4.General Requirements A fully automated medical sample processing system refers to a system that connects medical testing modules through automated tracks and information network technology to form a complete system. A complete detection system. A fully automated medical sample processing system typically consists of a sample input module, a centrifugation module, a capping module, a dispensing module, and a track module. It consists of modules such as block, interface module, capping module, sample output module, sample storage module, and software, but does not include sample reaction or signal acquisition and analysis. Modules can be freely combined and used by the manufacturer according to usage requirements. This document only covers the sample processing module in the integrated detection system. For modules and testing functions, please refer to relevant product standards. Modules or products not listed in this document should be identified by the manufacturer based on product characteristics and usage. The requirements should be specified accordingly.

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