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YY/T 1174-2010 English PDF

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YY/T 1174-2010: Semi-automatic chemiluminescence immunoassay analyzer
Status: Valid
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YY/T 1174-2010English209 Add to Cart 3 days [Need to translate] Semi-automatic chemiluminescence immunoassay analyzer Valid YY/T 1174-2010

PDF similar to YY/T 1174-2010


Standard similar to YY/T 1174-2010

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Basic data

Standard ID YY/T 1174-2010 (YY/T1174-2010)
Description (Translated English) Semi-automatic chemiluminescence immunoassay analyzer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 9,986
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 191; GB 4793.1-2007; GB/T 14710
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the semi-automatic chemiluminescence immunoassay analyzer requirements, test methods, marking, labeling and instructions, packaging, transportation and storage. This standard applies to semi-automatic chemiluminescence immunoassay analyzer detector section. This standard does not apply to the analyzer incubation, washing, pipetting, and other parts.

YY/T 1174-2010: Semi-automatic chemiluminescence immunoassay analyzer

---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.
Semi-automatic chemiluminescence immunoassay analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Semi-automatic chemiluminescence immunoassay analyzer Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard is evaluated semi-automatic chemiluminescence immunoassay analyzer based on product quality. 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 by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed. 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 on Pine Technology Co., Ltd., Beijing Science and Technology Co., quantity and quality. The main drafters of this standard. Wang Jun, Fu Yuguang, Jiang Hongwei. Semi-automatic chemiluminescence immunoassay analyzer

1 Scope

This standard specifies the semi-automatic chemiluminescence immunoassay analyzer requirements, test methods, marking, labeling and instructions, packaging, transport and Storage. This standard applies to semi-automatic chemiluminescence immunoassay analyzer (hereinafter referred to as the analyzer) detector portion. This standard does not apply to other parts of the analyzer incubation, washing, loading and so on.

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/T 191 Packaging - Pictorial signs GB 4793.1-2007 measurement, control and laboratory use safety requirements for electrical equipment - Part 1. General requirements GB/T 14710 medical electrical environmental requirements and test methods

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 CLIA chemiluminescenceimmunoassay It is a chemiluminescent immunoassay and combine technology, a series of immune response by an antigen or antibody labeled with the analytes, Finally, to determine the luminous intensity derived analyte content. 3.2 Chemiluminescence immunoassay analyzer chemiluminescenceimmunoassayanalyzer Chemiluminescence immunoassay as a basic principle, the use photoelectric detection technology, qualitative and (or) quantitative detection of the immune analyzer. 3.3 Manual or otherwise finished adding the sample, add reagents, mixing, washing, incubation and other parts or all of the work, and then automatically by the instrument Testing, calculation, report the results of chemiluminescence immunoassay analyzer.

4 Requirements

4.1 Metering Repeatability The coefficient of variation of the photometric value CV≤2%. 4.2 photometry value stability Relatively poor representation should be ≤3%.

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