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YY/T 0701-2021: Calibrator for hematology analyzer
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 0701-2021	English	259	Add to Cart	3 days [Need to translate]	Calibrator for hematology analyzer
YY/T 0701-2008	English	639	Add to Cart	3 days [Need to translate]	Calibrator for hematology analyzer

YY/T 0701-2021: Calibrator for hematology analyzer

---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.
Calibrator for hematology analyzer ICS 11:100:10 C44 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0701-2008 Calibrators for Hematology Analyzers Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Technical requirements 2 4:1 Appearance 2 4:2 Loading volume 2 4:3 Uniformity 3 4:4 Traceability3 4:5 Correctness 3 4:6 Accuracy 3 4:7 Stability 3 5 Test method 4 5:1 Appearance 4 5:2 Loading 4 5:3 Uniformity 4 5:4 Traceability5 5:5 Accuracy 5 5:6 Accuracy5 5:7 Stability5 6 Signs, labels, instruction manuals 7 7 Packaging, transport and storage 7 7:1 Packaging7 7:2 Transport7 7:3 Storage 7 Appendix A (Informative Appendix) Reference Method Standard 8 Reference 9

foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY/T 0701-2008 "Calibrators (products) for blood cell analyzers", compared with YY/T 0701-2008, except for editing The main changes in addition to the sexual modifications are as follows: --- Modify the standard name to calibrator for blood analyzers; ---The text description in the normative reference document is written according to GB/T 1:1-2009; --- Normative reference document changes; --- Increase the terms and definitions "accuracy" and "correctness"; --- Modification of appearance description; --- Modification of uniformity requirements; --- Traceability requirements modification; --- The accuracy of assignment requires modification; --- remove biosecurity; --- Stability requirements modification; --- Modification of uniformity method; --- Traceability method modification; --- Assignment accuracy method modification; --- Removal of biosecurity methods; --- Increase accuracy requirements and methods; --- Modification of stability testing method; --- Logos, labels, and instruction manuals are modified as usual; ---Packaging, transportation and storage are modified as usual: Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents: This standard is proposed by the State Drug Administration: This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136): This standard was drafted by: Beijing Medical Device Inspection Institute, Sysmex Medical Electronics (Shanghai) Co:, Ltd:, Beckman Coulter Trading (China) Co:, Ltd:, Shenzhen Mindray Biomedical Electronics Co:, Ltd:, Jiangxi Tekang Technology Co:, Ltd:, Abbott Trading (Shanghai) Co:, Ltd: company: The main drafters of this standard: Xu Yong, Su Jing, Yang Yuejuan, Xie Jian, Ouyang Minyong, Zhang Hong: The previous editions of the standard replaced by this standard are as follows: ---YY/T 0701-2008: Calibrators for Hematology Analyzers

1 Scope

This standard specifies the terms and definitions, technical requirements, test methods, signs, Labels and instructions, packaging, transportation and storage: This standard applies to calibrators for blood analyzers: This calibrator is only used for calibrating the white blood cells of a blood analyzer (also known as a blood cell analyzer): Cell count (WBC), red blood cell count (RBC), hemoglobin determination (HGB), mean hematocrit volume (MCV)/hematocrit determination (HCT), platelet count (PLT) five parameters, so as to establish the metrological traceability of the measurement results of the blood analyzer:

2 Normative references

The following documents are essential for the application of this document: For dated references, only the dated version applies to this article pieces: For undated references, the latest edition (including all amendments) applies to this document: GB/T 191-2008 Graphical signs of packaging, storage and transportation GB/T 29791:2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2: In vitro diagnostics for professional use break reagent

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 calibrator A measurement standard used for the calibration of in vitro diagnostic instruments or systems: [GB/T 29791:1-2013, definition 3:11] 3:2 homogeneity The concordance of the value of a particular property in specified parts of a reference material: [JJF1005-2016, Definition 3:14] 3:3 between-bottle homogeneity The properties of the reference material vary from bottle to bottle: [ISO GUIDE35:2006, Definition 3:5] NOTE: The term "bottle-to-vial uniformity" applies to other types of packaging (eg vials) and other physical shapes and test pieces: 3:4 In-bottle homogeneity within-bottlehomogeneity The properties of the reference material deteriorate in a bottle: [ISO GUIDE35:2006, definition 3:6] 3:5 reference method referencemethod A clearly and accurately described technique for a specific assay, based on evidence that provides highly accurate and precise experimental data ...