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YY/T 1967-2025: Bead-based flow cytometric analyzer
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1967-2025	English	299	Add to Cart	3 days [Need to translate]	Bead-based flow cytometric analyzer

YY/T 1967-2025: Bead-based flow cytometric analyzer

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ICS 11.100.10 CCSC44 Pharmaceutical Industry Standards of the People's Republic of China Flow cytometer Published on 2025-06-18 Implemented on July 1, 2026 National Medical Products Administration issued

Table of contents

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4 Requirements 2 5.Test Methods 4 6.Labeling, markings, and instructions for use 8. 7 Packaging, transportation and storage 8 Appendix A (Informative) Density of pure water at different temperatures under standard atmospheric pressure 9 References 10

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), Sichuan Provincial Institute of Pharmaceutical Research and Testing. Medical Device Inspection and Testing Institute (Sichuan Provincial Medical Device Testing Center), Beijing Medical Device Evaluation and Inspection Center, Beijing Zhizhen Biotechnology Co., Ltd. Company, Beijing Human Intelligent Manufacturing Technology Co., Ltd., Luminex Trading (Shanghai) Co., Ltd., Hubei Provincial Medical Device Quality Supervision and Inspection Institute Research Institute, Hubei Xinzongke Virus Disease Engineering Technology Co., Ltd. The main drafters of this document are. Sun Li, Qu Qian, Jiang Yan, Qin Xiaokun, Meng Zekai, Yin Xiaoting, Li Sijin, Xu Peng, and Wan Xinxin. Flow cytometer

1 Scope

This document specifies the requirements, marking, labeling and instructions for use, packaging, transportation and storage of flow cytometers, and describes the corresponding testing methods. method. This document applies to flow cytometers (hereinafter referred to as fractional cytometers) used in medical laboratories. Fractional cytometers are based on flow cytometry fluorescence technology and are used for... Qualitative and/or quantitative detection of various analytes, such as nucleic acids, proteins, peptides, and small molecules, in human samples.

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 4793.1 Safety requirements for electrical equipment for measuring, control and laboratory use - Part 1.General requirements GB 4793.6 Safety requirements for electrical equipment for measuring, controlling and laboratory use - Part 6.Special requirements for heating equipment for materials in laboratories Special requirements 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 18268.26 Electromagnetic compatibility requirements for electrical equipment for measuring, control and laboratory use - Part 26.Particular requirements External diagnostic (IVD) medical devices GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101.In vitro diagnostic (IVD) medical devices Special requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 High-throughput detection equipment based on flow cytometry technology performs qualitative analysis by identifying coded microspheres and the target substances bound to their surfaces. And/or quantitative detection. 3.2 High-throughput multiplex detection technology based on coded microspheres and flow cytometry enables simultaneous qualitative analysis of multiple analytes in the same sample. And/or quantitative detection. 3.3 semi-automatic A device that requires external operation to perform some or all of the following tasks. sample and reagent addition, mixing, washing, incubation, amplification, hybridization, etc. ...