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YY/T 1442-2016 English PDF

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YY/T 1442-2016: β2--Microglobulin quantitative detection reagents(kit)
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YY/T 1442-2016English159 Add to Cart 3 days [Need to translate] β2--Microglobulin quantitative detection reagents(kit) Valid YY/T 1442-2016

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Basic data

Standard ID YY/T 1442-2016 (YY/T1442-2016)
Description (Translated English) ��2--Microglobulin quantitative detection reagents(kit)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,849
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration

YY/T 1442-2016: β2--Microglobulin quantitative detection reagents(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.
β2 - Microglobulin quantitative detection reagents (kit) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard β2-microglobulin quantitative detection reagent (box) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is 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 release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Device Testing Institute, Shanghai Kehua Biological Engineering Co., Ltd., Capital Medical University Affiliated North Beijing Tong Ren Hospital, Zhengzhou Antu Biological Engineering Co., Ltd. The main drafters of this standard. Wang Ruixia, Peng Shan, Liu Xiangyi, Yang Hongyun. β2-microglobulin quantitative detection reagent (box)

1 Scope

This standard specifies the requirements, test methods, labeling, labeling, instruction manual, packaging, and shipping of the β2-microglobulin quantitative assay reagent (box) Lose and store. This standard applies to the antigen-antibody reaction as the basic principle of quantitative detection of blood samples or urine samples of β2-microglobulin reagent (Box) [hereinafter referred to as "β2-microglobulin reagent (box)"], the kit method includes quantitative labeling immunization method [such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro) chemiluminescence, etc.] and immunoturbidimetric methods (including immunoturbidimetry, latex Strong immunoturbidimetric method). This standard does not apply to the evaluation of β2-microglobulin calibrators and quality control products.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance The origin of traceability YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 request

3.1 appearance Should be based on the characteristics of the product packaging requirements of the appropriate appearance requirements, the general composition of the components of the kit should be, traits, inner and outer packaging, labels And so on. a) kit components should be complete, both inside and outside the packaging should be complete, clear label; b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation). 3.2 traceability Should be based on GB/T 21415-2008 and the relevant provisions of the β2-microglobulin calibrator used to provide the source, the assignment process and measurement is not Certainty and so on. 3.3 Accuracy Accuracy should meet one of the following requirements. a) Relative deviation. With a reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample, The relative deviation of the measurement results should not exceed ± 10%. b) Comparison test. β2-microglobulin reagent (box) and the specified analysis system for comparison test. 1) The correlation coefficient (r) should be not less than 0.950 and the slope should be within [0.9,1.1]

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