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YY/T 1234-2014 English PDF

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YY/T 1234-2014: Alkaline phosphatase test reagent kit (Method of NPP-AMP)
Status: Valid
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YY/T 1234-2014English279 Add to Cart 3 days [Need to translate] Alkaline phosphatase test reagent kit (Method of NPP-AMP) Valid YY/T 1234-2014

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Basic data

Standard ID YY/T 1234-2014 (YY/T1234-2014)
Description (Translated English) Alkaline phosphatase test reagent kit (Method of NPP-AMP)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 12,181
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 the use of AMP buffer, serum or plasma alkaline phosphatase activity quantitative detection of alkaline phosphatase assay reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used. This Standard

YY/T 1234-2014: Alkaline phosphatase test reagent kit (Method of NPP-AMP)

---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.
Alkaline phosphatase test reagent kit (Method of NPP-AMP) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Alkaline phosphatase assay reagent (kit) (NPP substrate -AMP buffer method) 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. Release mechanism of the present document does not assume responsibility for the identification of 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 Tongren Hospital, Capital Medical University, Beijing Medical Sciences Branch Kang Datai Technology Co., Ltd., BIOSINO Biotechnology Co., Ltd.. The main drafters of this standard. Wang Jun, Liu Xiang Yi, Wang Li, Zhang Yongqin, Duhai Ou. Alkaline phosphatase assay reagent (kit) (NPP substrate -AMP buffer method)

1 Scope

This standard specifies the alkaline phosphatase assay reagent (kit) technical requirements, test methods, labels, brochures, packaging, transport and Storage. This standard applies to the determination of alkaline phosphatase using AMP buffer, serum or plasma alkaline phosphatase activity quantitative detection Reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used. This standard does not apply to dry-type alkaline phosphatase 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 calibrator measured in vitro diagnostic medical devices samples of biological origin and quality control measurement of the amount of material assigned school Traceability 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 samples of biological origin quantity measurement calibration and quality control material for catalytic concentration of enzymes assigned Metrological traceability of values

3 Requirements

3.1 Appearance In line with the provisions of the company's normal appearance requirements. 3.2 PACKING Net content of the liquid reagent to be less than indicated value. 3.3 reagent blank 3.3.1 Reagent blank absorbance Reagent blank absorbance should be consistent with the company given range. 3.3.2 Reagent blank absorbance change rate With saline as the test sample was added to the reagent, the reagent blank absorbance change rate (ΔA/min) should be less than 0.005. 3.4 Sensitivity Analysis Test 120U/L alkaline phosphatase, the rate of change of the absorbance of the company in line with the given range.

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