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YY/T 1253-2015: Low density lipoprotein (LDL) cholesterol assay kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1253-2015 | English | 189 |
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Low density lipoprotein (LDL) cholesterol assay kit
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YY/T 1253-2015
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Basic data | Standard ID | YY/T 1253-2015 (YY/T1253-2015) | | Description (Translated English) | Low density lipoprotein (LDL) cholesterol assay kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,955 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | YY/T 0466.1 | | 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 low-density lipoprotein cholesterol assay reagent (kit) requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This Standard applies to the use of the direct method in human serum or plasma low-density lipoprotein cholesterol quantitative detection reagent (kit), based on the principle of spectrophotometry, including manual reagents and on the semi-automatic biochemical analyzer used. | YY/T 1253-2015: Low density lipoprotein (LDL) cholesterol assay 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.
Low density lipoprotein (LDL) cholesterol assay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
LDL cholesterol assay reagent (kit)
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, Beijing Leadman Biochemistry Co., Ltd., Hitachi High-Technologies (Shanghai) State
International Trade Co., Ltd. Beijing Branch, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Pharmaceutical Co., Ltd. Rongsheng Sheng matter.
The main drafters of this standard. Bi Chunlei, Wang Lanzhen, Cheng Qing, Wang Jun, Tang Wei, Zhang Zhengjiang.
LDL cholesterol assay reagent (kit)
1 Scope
This standard specifies the low-density lipoprotein cholesterol assay reagent (kit) requirements, test methods, marking, labeling and instructions for use, package
Loading, transportation and storage.
This standard applies to the use of the direct method in human serum or plasma low-density lipoprotein cholesterol quantitative detection reagent (box), the base
Spectrophotometry in principle, including manual reagents and on the semi-automatic biochemical analyzer used.
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 Appearance
3.1.1 Kit components should be complete, complete, no liquid leakage.
3.1.2 Packaging label text symbols should be clear.
3.2 PACKING
Not less than the indicated value.
3.3 reagent blank absorbance
When adding reagent blank sample test, the absorbance of the reagent blank should be < 0.05.
3.4 Sensitivity Analysis
Determination of 1.00mmol/L samples, the absorbance difference (ΔA) should be > 0.03.
3.5 Linear
Reagent (box) within the linear [0.30,10.00] mmol/L range.
a) The linear correlation coefficient (r) shall be not less than 0.995;
b) within [0.30,10.00] mmol/L range, linearity deviation should not exceed ± 0.30mmol/L or no more than ± 10%.
3.6 Precision
3.6.1 Repeatability
Repeat the test (2.50 ± 0.50) mmol/L and (5.00 ± 1.00) mmol/L in the sample, the results of the coefficient of variation (CV) should not
3%.
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