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JJF 1665-2017 English PDF

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JJF 1665-2017: Calibration Specification for Flow Cytometers
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Standard similar to JJF 1665-2017

JJF 1835   JJF 1800   JJF 1071   JJF 1261.6   JJF 1261.5   JJF 1666   

Basic data

Standard ID JJF 1665-2017 (JJF1665-2017)
Description (Translated English) Calibration Specification for Flow Cytometers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 16,120
Date of Issue 2017-11-20
Date of Implementation 2018-02-20
Regulation (derived from) AQSIQ Notice 2017 No. 103
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine

JJF 1665-2017: Calibration Specification for Flow Cytometers

---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.
Calibration Specification for Flow Cytometers People's Republic of China National Metrology Technical Specifications Flow Cytometer Calibration Specifications Published on.2017-11-20 2018-02-20 Implementation The State Administration of Quality Supervision, Inspection and Quarantine issued Flow Cytometer Calibration Specifications FlowCytometers Undertaking unit. National Biometrics Technical Committee Drafted by. China Academy of Metrology Participated in drafting. Beckman Coulter Trade China Beijing Shenmeirui Medical Electronic Technology Research Institute Co., Ltd. Biodi Medical Devices (Shanghai) Co., Ltd. This specification entrusts the National Biometrics Technical Committee to explain The main drafters of this specification. Zhang Ling (China Institute of Metrology) Liu Yingying (China Academy of Metrology) Yan Zhiwei (China Institute of Metrology) Participating drafters. Pan Na (Beckman Coulter China Trading Company) Dong Lifang (Beijing Shenmeirui Medical Electronic Technology Research Institute Co., Ltd.) Song Zhihua [BIDI Medical Devices (Shanghai) Co., Ltd.]

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 Terms (1) 3.1 equivalent soluble fluorescent molecules (1) 4 Overview (1) 5 Metrological characteristics (1) 5.1 Resolution (1) 5.2 Linear Correlation Coefficient (1) 5.3 Detection Limit (1) 5.4 Drift (1) 5.5 Repeatability (1) 5.6 Indication Error (1) 6 Calibration Conditions (2) 6.1 Environmental Conditions (2) 6.2 Reference materials and calibration equipment (2) 7 Calibration Items and Calibration Methods (3) 7.1 Resolution (3) 7.2 Linear Correlation Coefficient (3) 7.3 Detection Limit (4) 7.4 Drift (4) 7.5 Repeatability (5) 7.6 Indication Error (5) 8 Expression of Calibration Results (5) 9 Re-school interval (6) Appendix A Calibration Original Record Reference Format (7) Appendix B Recommended format of the calibration page (9) Appendix C Example of Evaluation of Uncertainty in Calibration of Indicating Errors (10)

Introduction

This specification mainly refers to the JJG1061-2010 "Liquid Particle Counter" and the pharmaceutical industry standard YY/T 0588- 2005 Flow Cytometry. This specification is the first release. Flow Cytometer Calibration Specifications

1 Scope

This specification applies to the calibration of an analytical flow cytometer based on the fluorescence detection principle. Other types of flow cells Instrument (hereinafter referred to as the instrument) can be implemented with reference to this specification.

2 references

This specification refers to the following documents. JJF 1071-2010 Rules for the preparation of national metrological calibration specifications JJF 1265 Biometric Terms and Definitions For dated references, only dated editions apply to this specification; all undated references The latest version (including all amendments) applies to this specification.

3 Terms

The definitions of JJF 1265 and the following terms and definitions apply to this specification. 3.1 equal amounts of soluble fluorescent molecules moleculesofequivalentvalentfluorochrome, MESF The intensity of the fluorescence signal emitted by the particles is comparable to that of the soluble fluorescein molecule. Used to represent particles The intensity of the fluorescent signal emitted.

4 Overview

The flow cytometer consists of four parts. the flow system, the optical system, the detection system, and the analysis system (see Figure 1). The measuring principle is that the sheath fluid and the sample flow form a cylindrical stream near the nozzle, perpendicular to the horizontal laser beam. Cross-stained cells fluoresce or scatter light upon irradiation with laser light. These signals are respectively emitted by photomultiplier tubes. Detectors and photodiode scattered light detectors receive, store, calculate and analyze these digitized letters via computer The physical and biochemical indicators such as cell size, activity, nucleic acid content, enzyme and antigen properties can be obtained.

5 Metrological characteristics

5.1 Resolution 5.2 Linear Correlation Coefficient 5.3 Detection limit 5.4 Drift 5.5 Repeatability 5.6 Indication Error

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