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YY/T 1202-2013: Kalium assay kit(Enzymic method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1202-2013 | English | 229 |
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Kalium assay kit(Enzymic method)
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YY/T 1202-2013
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Basic data | Standard ID | YY/T 1202-2013 (YY/T1202-2013) | | Description (Translated English) | Kalium assay kit(Enzymic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,145 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | The standard provides: potassium assay kit (enzymatic) Determination of Principles, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: potassium assay kit (enzymatic) Qu | YY/T 1202-2013: Kalium assay kit(Enzymic method)---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.
Kalium assay kit (Enzymic method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Potassium Assay Kit (enzymatic)
Issued on. 2013-10-21
2014-10-01 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 standard may involve patents. The standard release
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 drafting unit. China Academy of Food and Drug test.
The main drafters of this standard. Wang Yumei, Liu Yan, the first noble.
Potassium Assay Kit (enzymatic)
1 Scope
This standard specifies the potassium assay kit (enzymatic) measurement principle, requirements, test methods, marking, labeling and instructions for use, packaging, transport
Transport and storage.
This standard applies to potassium assay kit (enzymatic) quality control, the product is for in vitro quantitative determination of human serum or plasma potassium
Amount.
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 Principle of Measurement
Phosphoenolpyruvate and adenosine diphosphate (ADP) in potassium - pyruvate and adenosine triphosphate-dependent under the effect of pyruvate kinase
(ATP), the resulting pyruvate and reduced coenzyme I (NADH) generated L- lactic acid and oxidized coenzyme Ⅰ in lactate dehydrogenase role.
NADH and is directly proportional to the rate of decrease in potassium ion concentration in the specimen, changes in absorbance of NADH was monitored at a wavelength of 340nm in the meter can be
Calculating potassium content.
4 Requirements
4.1 Appearance
Compatible with the manufacturer's normal appearance requirements.
4.2 PACKING
Net content of the liquid reagent to be less than the labeled amount.
4.3 reagent blank
4.3.1 Reagent blank absorbance
Reagent 2 (R2) was added immediately measured absorbance of the reagent blank should not be less than 1.0 (wavelength 340nm, optical path 1cm).
4.3.2 Reagent blank absorbance change rate
It should be less than 0.200/min.
4.4 Linear Interval
In 2.5mmol/L ~ 7mmol/L range, the linear theory and measured concentrations concentration correlation coefficient r should not be less than 0.9900.
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