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YY/T 1580-2018 English PDF

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YY/T 1580-2018: Creatine kinase MB isoenzyme(CK-MB) testing kit(immunesuppression)
Status: Valid
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YY/T 1580-2018English159 Add to Cart 3 days [Need to translate] Creatine kinase MB isoenzyme(CK-MB) testing kit(immunesuppression) Valid YY/T 1580-2018

PDF similar to YY/T 1580-2018


Standard similar to YY/T 1580-2018

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Basic data

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 8,822
Date of Issue 2018-02-24
Date of Implementation 2019-03-01
Quoted Standard GB/T 29791.2
Regulation (derived from) China Food and Drug Administration announced No. 27 of 2018
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: Creatine kinase MB isoenzyme(CK-MB) testing kit(immunesuppression)

---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.
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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