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YY/T 1241-2014 English PDF

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YY/T 1241-2014: L-Lactate dehydrogenase test reagent reagent(kit)
Status: Valid
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YY/T 1241-2014English279 Add to Cart 3 days [Need to translate] L-Lactate dehydrogenase test reagent reagent(kit) Valid YY/T 1241-2014

PDF similar to YY/T 1241-2014


Standard similar to YY/T 1241-2014

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Basic data

Standard ID YY/T 1241-2014 (YY/T1241-2014)
Description (Translated English) L-Lactate dehydrogenase test reagent reagent(kit)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 12,176
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB 3100; GB/T 21415; YY/T 0316; YY/T 0466.1; YY/T 0638
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 lactate as substrate, using continuous monitoring method for serum or plasma lactate dehydrogenase activity quantitative detection of lactate dehydrogenase assay reagent (box), including manual reagents and in semi-automatic bioch

YY/T 1241-2014: L-Lactate dehydrogenase test reagent reagent(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.
L-Lactate dehydrogenase test reagent reagent (kit) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Lactate dehydrogenase assay reagent (kit) L-Lactatedehydrogenasetestreagent (kit) 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. 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, BIOSINO Biotechnology Co., Ltd., Beijing Leadman Biochemistry Shares Ltd., Beckman Coulter Limited. The main drafters of this standard. Wang Jun, Du Haiou, Yuecai Qin, Wang Lanzhen, Yin Qi Man. Lactate dehydrogenase assay reagent (kit)

1 Scope

This standard specifies the lactate dehydrogenase assay reagent (box) terms and definitions, requirements, test methods, labels, brochures, packaging, transport Transport and storage requirements. This standard applies to lactate as substrate using the method of continuous monitoring of serum or plasma lactate dehydrogenase activity quantitative detection Lactate dehydrogenase assay reagent (kit), including manual reagents and on the semi-automatic biochemical analyzer used. This standard does not apply to dry-type lactate dehydrogenase assay reagent (kit).

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 3100 International System of Units and Its Application GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived YY/T 0316 Medical Devices Risk Management for Medical Device Applications Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements YY/T 0638 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials in enzymatic concentration assignment Metrological traceability

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Continuous monitoring method continuous-monitoring Under optimum conditions the enzyme reaction, multi-point monitoring throughout the course of the enzymatic reaction product or a reaction in the substrate due to changes over time Case, the reaction rate constant period, in the initial reaction rate per unit time of enzyme activity concentration of the enzyme was calculated.

4 Requirements

4.1 Appearance In line with the provisions of the company's normal appearance requirements. 4.2 PACKING Loading amount of the liquid reagent to be less than indicated value. 4.3 reagent blank 4.3.1 Reagent blank absorbance At 37 ℃, 340nm wavelength, under 1cm light path conditions, absorbance of the reagent blank should be less than 0.50.

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