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YY/T 0701-2021: Calibrator for hematology analyzer
Status: Valid YY/T 0701: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0701-2021 | English | 259 |
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Calibrator for hematology analyzer
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YY/T 0701-2021
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| YY/T 0701-2008 | English | 639 |
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Calibrator for hematology analyzer
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YY/T 0701-2008
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PDF similar to YY/T 0701-2021
Basic data | Standard ID | YY/T 0701-2021 (YY/T0701-2021) | | Description (Translated English) | Calibrator for hematology analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 13,151 | | Issuing agency(ies) | State Drug Administration | 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
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