YY/T 1580-2018_English: PDF (YY/T1580-2018)
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Creatine kinase MB isoenzyme(CK-MB) testing kit(immunesuppression)
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YY/T 1580-2018
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Standard ID | YY/T 1580-2018 (YY/T1580-2018) | Description (Translated English) | Creatine kinase MB isoenzyme(CK-MB) testing kit(immunesuppression) | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Classification of International Standard | 11.100 | Word Count Estimation | 8,826 | Date of Issue | 2018-02-24 | Date of Implementation | 2019-03-01 | Quoted Standard | GB/T 29791.2 | Drafting Organization | Beijing Medical Device Inspection Institute | Administrative Organization | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | Regulation (derived from) | China Food and Drug Administration announced No. 27 of 2018 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation, and storage of the creatine kinase MB isoenzyme assay kit. This standard applies to the creatine kinase MB isoenzyme assay kit (immunosuppression method) (hereinafter referred to as the kit), including reagents used on manual and semi-automatic, automatic biochemical analyzers. |
YY/T 1580-2018
Creative kinase MB isoenzyme(CK-MB) testing kit(immunesuppression)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Creatine kinase MB isoenzyme assay kit
(immunosuppression method)
CreatinekinaseMBisoenzyme(CK-MB) testingkit
Published on.2018-02-24
2019-03-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Zhongsheng Beikong Biotechnology Co., Ltd., and Xisen Meikang Biotechnology (None
Tin) Co., Ltd., Shandong Boko Bio-Industry Co., Ltd., Zhengzhou Antu Bio-engineering Co., Ltd.
The main drafters of this standard. Yang Zongbing, Wang Yunfeng, Zhang Jie, Tan Baiqing, Zhang Lihong.
Creatine kinase MB isoenzyme assay kit
(immunosuppression method)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use of the creatine kinase MB isoenzyme assay kit, packaging, transportation and
Storage.
This standard applies to the creatine kinase MB isoenzyme assay kit (immunosuppression method) (hereinafter referred to as the kit), including manual and semi-self
Reagents used on dynamic and fully automated biochemical analyzers.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The components of the kit should be complete and complete, and the liquid should be free of leakage.
3.2 Loading
It should be no less than the value indicated.
3.3 Reagent blank
3.3.1 Reagent blank absorbance
When using a blank sample to add a reagent test, the reagent blank absorbance should be small at the measurement wavelength (1 cm diameter) specified in the kit instructions.
At 0.5.
3.3.2 Reagent blank absorbance change rate
When a blank sample is added to the reagent test, the reagent blank absorbance change rate (ΔA/min) should be no more than 0.002.
3.4 Analytical sensitivity
When measuring a 100 U/L sample, the rate of change in absorbance (ΔA/min) should be not less than 0.008.
3.5 linear
The linear range of the kit should cover [10,200] U/L, which should be consistent in this interval.
a) the linear correlation coefficient (r) should be not less than 0.990;
b) In the [10,50] U/L interval, the linear deviation should not exceed ±2.5 U/L; in the (50,200) U/L interval, the linear deviation should not exceed
±5%.
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