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YY/T 1246-2014Glycohemoglobin analyzer (English PDF)

糖化血红蛋白分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 1246-2014 is the English-translated version of 糖化血红蛋白分析仪.

YY/T 1246-2014 is the Chinese pharmaceutical industry standard for the glycohemoglobin analyzer, the instrument that measures glycated haemoglobin in whole blood.

It specifies the requirements, the test methods, the signs, the labels, the instruction manual and the rules for packaging, transport and storage, covering the accuracy and repeatability of the result, the linearity and the carry-over, the stability of the calibration, the resistance to interference by haemoglobin variants and the electrical safety. Issued on 17 June 2014, it has applied since 1 July 2015.

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Document preview — YY/T 1246-2014

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Requirements

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

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