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YY/T 1967-2025Bead-based flow cytometric analyzer (English PDF)

流式点阵仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 18, 2025

Implementation date

July 1, 2026

Scope

YY/T 1967-2025 is the English-translated version of 流式点阵仪.

YY/T 1967-2025 is the Chinese standard "Bead-based flow cytometric analyzer". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 1967-2025

National Standard of the People's Republic of China

ICS: 11.100.10
Classification: C44

Issued by: National Medical Products Administration

Preface
1.Scope
2 Normative References
3.Terms and Definitions
4 Requirements
5.Test Methods
7 Packaging, transportation and storage
Appendix A (Informative) Density of pure water at different temperatures under standard atmospheric pressure
References

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.

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 14 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1709|YY/T 1713|YY/T 1721|YY/T 1961|YY/T 1958

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