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YY/T 0702-2008: Control material for hematology analyzer
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0702-2008 | English | 279 |
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Control material for hematology analyzer
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YY/T 0702-2008
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Basic data | Standard ID | YY/T 0702-2008 (YY/T0702-2008) | | Description (Translated English) | Control material for hematology analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 12,139 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Quoted Standard | GB 9969.1-1998; JJF 1001-1988; JJF 1005-2005; WS/T 124-1999 | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the blood cell analyzer with control material (goods) (hereinafter referred to as quality control material) terms and definitions, nomenclature and classification, technical requirements, test methods, inspection rules, marks, labels and brochures, packaging, transport and storage. This standard does not give the WBC graphics quality control material technical requirements. This standard applies to the blood cell analyzer with quality control material, quality control material used for monitoring or evaluation of blood cell analyzer (also known as blood analyzers) test results accuracy. | YY/T 0702-2008: Control material 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.
Control material for hematology analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Hematology analyzer with quality control material (product)
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
Foreword
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard was drafted. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Beijing Medical Device Testing, Sysmex Medical electrical
Sub (Shanghai) Co., Ltd. Jiang Xi Tekang.
The main drafters of this standard. Cong Yu Long, Yang Hongwei, Zhang Hong, Zhang Hui, Xiao Yan, continued courage.
Hematology analyzer with quality control material (product)
1 Scope
This standard specifies the hematology analyzer with quality control material (product) (hereinafter referred to as quality control material) terms and definitions, naming and classification technology to
Requirements, test methods, inspection rules, signs, labels and instructions, packaging, transport and storage. This standard does not give quality control substance of leukocyte classification map
Shape technical requirements.
This standard applies to the blood cell analyzer using quality control material, quality control material used to monitor or evaluate the hematology analyzer (also known as blood analyzers) inspection
Precision measurement results.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9969.1-1998 Instructions General Industrial Products
JJF1001-1988 common measurement terms and definitions
JJF1005-2005/ISO Guide 30.1992 standard materials commonly used terms and definitions
WS/T 124-1999 clinical chemistry in vitro diagnostic kit for Quality Inspection General
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Having one or more sufficiently homogeneous and well established characteristics used to calibrate the measuring device or measuring method to evaluate the material assignment
A material or substance.
[JJF1001-1998, definitions 8.13/VIM definitions 6.13]
3.2
It is a stable material, equipment or procedures for checking the performance of analytical instruments or methods. When the substance of the instruments used to check or party
When the current method of routine test performance, it must analyze the characteristics of patients with similar samples.
3.3
On the Identity value quality control substance, manufacturers need to provide a reference value and the reference range.
3.4
On the identification of non-value quality control substance, manufacturers are not required to provide a reference value and the reference range, without specifying a particular analysis system.
3.5
With one or more properties of the material associated with the same structure or composition of the state. By measuring from different packing units (such as.
Sample bottles, bags, etc.) or from the same packaging unit, the specific size measurements fall within the specified range of uncertainty can be considered standard
The amount of the material properties of the specified uniform.
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