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YY/T 0501-2014: Urine dry chenistry analysis control material
Status: Valid YY/T 0501: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0501-2014 | English | 169 |
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Urine dry chenistry analysis control material
| Valid |
YY/T 0501-2014
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| YY/T 0501-2004 | English | 279 |
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Urinalysis control
| Obsolete |
YY/T 0501-2004
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PDF similar to YY/T 0501-2014
Basic data | Standard ID | YY/T 0501-2014 (YY/T0501-2014) | | Description (Translated English) | Urine dry chenistry analysis control material | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,722 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0501-2004 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the urine dry chemistry. This Standard specifies requirements for quality control of chemical analysis of urine dry matter, test methods, marking, labeling and instructions for use, packaging, transport and storage and so on. | YY/T 0501-2014: Urine dry chenistry analysis control material---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.
Urine dry chenistry analysis control material
ICS 11.100
C40
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0501-2004
Urine dry chemical analysis of quality control material
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Instead of the standard YY/T 0501-2004 "urinalysis quality control material", compared with the YY/T 0501-2004, the main technical change
as follows.
--- Standard name "urinalysis control material" to "quality control material for chemical analysis of urine dry";
--- Require content "working conditions" is adjusted to the test method;
--- Loading capacity requirements "liquid quality control material loading amount of the maximum negative deviation of 2%" to "loading amount should not be less than the nominal value";
--- Increased requirements "set nominal value", which increases the content "except gravity, pH, the nominal value of the positive control were at least high
In a negative order of magnitude or two settings ";
--- "Accuracy" to "QC Test value", the contents of "bilirubin, urobilinogen, ketones, blood (occult blood, hemoglobin), nitrous acid
Negative Control salts, leukocytes, glucose and albumin items shall not be detected positive results can not be measured by the positive control was negative
Results "was changed to" Test results shall meet the requirements of quality control material provisions ";
--- "Within run precision" to "uniformity", the corresponding content was revised to "projects of the test results should be consistent level
100% ";
--- "Stability during storage" to "stable";
--- "After opening shelf stability" to "Kaifeng (dissolved) after stability", the corresponding content was revised to "take or dissolved after Kaifeng
Quality control material, under specified conditions of storage to stabilize the end of the test, the test results should meet the requirements of 3.4.2. ";
--- "Under storage conditions stability" to "lifetime stability", the respective content modifications measure as "quality control was taken to after the limitation period
Test, test results should meet the requirements of 3.4.2,3.5. "
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.
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, Changchun Dheere Medical Technology Co., Ltd. Guilin gifted Litvin Medical Electronics
Limited.
The main drafters of this standard. Yangzong Bing, Gu Xiaofeng, Xianqing Yong.
This standard was first released in 2004.
Urine dry chemical analysis of quality control material
1 Scope
This standard specifies requirements for dry chemical analysis of urine quality control material, test methods, marking, labeling and instructions for use, packaging, transport and storage
Memory and so on.
This standard applies to urine, dry chemical analysis quality control material (hereinafter referred to as quality control material).
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 Requirements
3.1 Appearance
Appearance should meet the following requirements.
A) After mixing the liquid quality control material should not precipitate and floc;
b) freeze-dried powder was dissolved QC should be no precipitate and floc;
c) test strip quality control material should be uniform color, no spots or stains, extractables should be no precipitate and floc.
3.2 PACKING
Loading amount should not be less than the nominal value.
Setting the nominal value of 3.3
In addition to specific gravity, pH, the nominal value of the positive control was at least an order of magnitude or two higher than the negative order of settings.
3.4 Quality Control Test value
3.4.1 gravity deviation pH, glucose, albumin and projects the average of the test results and the nominal value shall be in accordance with Table 1 requirements.
Table 1 deviation proportion, pH, glucose and albumin projects
Categories proportion pH dextrose albumin
Negative Control was
Positive Control was
≤0.005 ≤0.2
≤1.0mmol/L ≤0.05g/L
≤14mmol/L when,
Relative deviation ≤10%
≤1.0g/L when,
Deviation ≤0.2g/L
> 14mmol/L, the
Relative deviation ≤5%
> 1.0g/L, the
Relative deviation ≤15%
3.4.2 Test results shall meet the requirements of quality control material requirements.
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