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YY/T 1255-2015: Immunoturbidimetry reagent (kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1255-2015 | English | 189 |
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Immunoturbidimetry reagent (kit)
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YY/T 1255-2015
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Basic data | Standard ID | YY/T 1255-2015 (YY/T1255-2015) | | Description (Translated English) | Immunoturbidimetry reagent (kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,942 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | GB/T 21415 | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the immunoturbidimetric assay reagent (kit) (transmission method) of terms and definitions, requirements and test methods, marking, labeling and instructions for use, packaging, transportation and storage. This Standard applies to the transmission based on the principles of immunoturbidimetry on semi-automatic biochemical analyzer, or other types of analyzers for quantitative reagent (kit). | YY/T 1255-2015: Immunoturbidimetry reagent (kit)---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.
Immunoturbidimetry reagent (kit)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Immunoturbidimetric assay reagent (kit) (transmission method)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Shanghai Fuxing Changzheng Medical Science Co., Beckman Coulter laboratory frame
EC (Suzhou) Co., Ltd., Sichuan Mike Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd.
The main drafters of this standard. Bi Chunlei, Wu Jie, Kang Juan, Zhang Yan, Chen Qiyun, Tian Wei.
Immunoturbidimetric assay reagent (kit) (transmission method)
1 Scope
This standard specifies the immunoturbidimetric assay reagent (kit) (transmission method) terms and definitions, requirements and test methods, marking, labeling, and so
With instructions, packaging, transportation and storage.
This standard applies to transmission-based Immunoturbidimetry principle, the semi-automatic biochemical analyzer or other type of analyzer given
Amount detection reagent (box).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability
Derived
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Immunoturbidimetry immunoturbidimetry
In the reaction solution, and the antibody-antigen complex formed by precipitation, so that increase in turbidity. When light passes through the reaction solution, some of the light is like
Product scattering some of the light is absorbed by the sample, the remaining light transmitted through the sample. The method of measuring the light absorption of the sample is immune nephelometry. Turbidimetric is
Spectrophotometric determination Principle.
In a fixed-angle scattered light scattering measurements turbidity (nephelometry).
Analyte concentration can be obtained by comparison with known concentration calibration solution is measured.
3.2
Blank limit limitofblank; LoB
Under certain probability, by a given measurement procedures measure up to the measurement results may be obtained blank sample.
[CLSIEP17-A, 3]
4 requirements and test methods
4.1 Appearance
Appearance should meet the following requirements.
a) the components of the kit should be complete, complete, no liquid leakage;
b) packaging label text symbols should be clear.
4.2 PACKING
Packed reagent amount not less than the indicated value.
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