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YY/T 0478-2011: Reagent strips for urinalysis
Status: Valid YY/T 0478: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0478-2011 | English | 169 |
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Reagent strips for urinalysis
| Valid |
YY/T 0478-2011
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| YY/T 0478-2004 | English | 319 |
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General technical requirements for chemical reagent strips for urinalysis
| Obsolete |
YY/T 0478-2004
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PDF similar to YY/T 0478-2011
Basic data | Standard ID | YY/T 0478-2011 (YY/T0478-2011) | | Description (Translated English) | Reagent strips for urinalysis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,711 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY/T 0478-2004 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food & Drug Administration Announcement 2011 No.106; Industry Standard Filing Announcement 2013 No.6 (Total No.162) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions urinalysis test strip, requirements, test methods, signs, label and instructions for use, packaging, transport and storage and so on. This standard applies to the use of the chemical reaction principle for the analysis of urine analysis test strip. | YY/T 0478-2011: Reagent strips for urinalysis---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.
Reagent strips for urinalysis
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0478-2004
Analysis of the urine test strip
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
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. Release mechanism of the present document does not assume responsibility for the identification of these patents.
Instead of the standard YY/T 0478-2004 "dry chemical urinalysis test strip General technical conditions", and YY/T 0478-2004 standard
Quasi compared to the main changes are as follows.
--- Standard name "dry chemical urinalysis test strip General technical conditions" to "urine analysis test strip";
--- Remove the "Introduction";
--- Deleted the term "urine sample," "sensitivity" and "analytical specificity", "false negative", "false positives", "accuracy", "precision
Degree "," quality control materials "," reference solution "," color ";
--- Increasing the term "order of magnitude";
--- Accuracy requirements added content "may not appear backward difference. The positive result may not appear negative, negative results may not appear
Positive ";
--- "Within run precision" to "repetitive", "inter-assay precision" to "inter-assay poor";
--- Repetitive claims "a difference of no more than two orders of magnitude in the same direction" to "consistency of test results is not less than 90%";
--- Batch difference between the requirements of "a difference of no more than two orders of magnitude in the same direction" to "do not differ by more than one order of magnitude";
--- Merge "analytical specificity" and "Vitamin C anti-noise" related content "analytical specificity";
--- Remove the "visual method" 2004 version 6.1.1 and the "Instrument Detection" 2004 version 6.1.2;
--- "Sensitivity range" to "limit of detection", modify the contents of the "first non-negative except for the amount of gravity and pH of each test items outside
Level should be checked out. "
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/T 136) focal point.
This standard was drafted. Beijing Medical Device Testing, Panyu District, Guangzhou Huaxin Technology Co., Ltd. Guilin gifted Litvin Medical Electronics
Ltd., Roche Diagnostics (Shanghai) Co., Ltd. Jiang Xi Tekang.
The main drafters of this standard. Yang Zongbing, Zhanghao Jia, Wang Zhenghua, Tian Wei, Xiao Yan, Du Haiou.
Analysis of the urine test strip
1 Scope
This standard specifies the terms and definitions urinalysis test strip, requirements, test methods, marking, labeling and instructions for use, packaging, transportation
And storage and so on.
This standard applies to the use of chemical reaction principle urine analysis urine analysis test strip.
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 191 Packaging - Pictorial signs
3 Terms
The following terms and definitions apply to this document.
3.1
Welterweight level
Each level corresponds to a qualitative range of concentrations.
Note 1. usually expressed as a nominal value within the range of concentrations;
Note 2. Each manufacturer claims that the order may be different.
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) surface should be smooth, burr-free edge;
b) test block should be firmly fixed to the base film, there is not a defect or loss;
c) test block appearance neat, uniform color, can not have spots or stains.
4.2 Accuracy
Test results with the corresponding reference solution with a difference to the declared value of not more than one order of magnitude, with no reverse difference. No positive reference solution
Negative result was negative reference solution can not be a positive result.
4.3 Repeatability
The consistency of test results is not less than 90%.
4.4 The detection limit
In addition to specific gravity and pH of the first non-negative magnitude outside of each test items should be able to be detected.
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