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YY/T 1246-2014 English PDF

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YY/T 1246-2014: Glycohemoglobin analyzer
Status: Valid
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PDF similar to YY/T 1246-2014


Standard similar to YY/T 1246-2014

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Basic data

Standard ID YY/T 1246-2014 (YY/T1246-2014)
Description (Translated English) Glycohemoglobin analyzer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,861
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; YY 0648
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 human blood glycated hemoglobin (HbA1c) concentration detection instruments; applicable instrument contains glycated hemoglobin (HbA1c) test items in the project, the evaluation of the instrument glycated hemoglobin detection modu

YY/T 1246-2014: Glycohemoglobin analyzer

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Glycohemoglobin analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Glycated hemoglobin analyzer 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, Shanghai Huizhong Medical Technology Co., Ltd., Sysmex Medical Electronics (Shanghai) Ltd., Chinese Academy of Food and Drug test. The main drafters of this standard. Continued Yong, He Xueying, Dai Changsheng, Fan Yijing, Wang Jianyu. Glycated hemoglobin analyzer

1 Scope

This standard specifies the glycated hemoglobin analyzer (hereinafter referred to as the analyzer) requirements, test methods, sign, label, manual, Packaging, transport and storage. This standard applies to. --- On human blood glycated hemoglobin (HbA1c) concentration detection equipment; --- Instrument test items contained in glycated hemoglobin (HbA1c) project, review the instrument glycated hemoglobin detection module. This standard does not apply to non-professional use of human blood glycated hemoglobin (HbA1c) concentration in non-laboratory use Detection equipment.

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 measurement, control and laboratory use safety requirements for electrical equipment - Part 1. General requirements GB/T 14710 medical electrical environmental requirements and test methods YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements

3 Requirements

3.1 result reporting unit Glycated hemoglobin (HbAlc) in IFCC units (mmol/mol) and derived NGSP units (%) reports. Note 1. between IFCC units (mmol/mol) and NGSP units (%) conversion can use the IFCC-NGSP conversion formula. NGSP value (%) = 0.09148 × IFCC values (mmol/mol) 2.152; Note 2. The above information comes from the 2010 American Diabetes Association (ADA), the European Society of Diabetes (EASD), International Diabetes Federation (IDF), the International Children's And Juvenile Diabetes Association (ISPAD), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), published in 2010 global HbA1c standardization Determination of consensus. 3.2 Accuracy Reference substance as a sample for testing, the relative deviation analyzer results should be within ± 8% range. 3.3 Repeatability Sample concentration was detected 4.0% ~ 6.5% (20.2mmol/mol ~ 47.5mmol/mol) of the sample, the analyzer becomes repeated measurements Coefficient of variation CV should not exceed 3.0%. 3.4 Linear Within the company claims analyzer range, the test results of linear correlation coefficient (r) shall not be less than 0.9900.

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