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YY/T 1251-2014Erythrocyte sedimentation rate analyzer (English PDF)

红细胞沉降率测定仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 1251-2014 is the English-translated version of 红细胞沉降率测定仪.

YY/T 1251-2014 is the Chinese pharmaceutical industry standard for the erythrocyte sedimentation rate analyser, the instrument that measures how far red cells settle in a column of blood in a given time.

It sets the requirements for the analyser and the test methods for them, and the rules for labels, marks, instructions for use, packaging, transport and storage.

The requirements cover the agreement of the result with the reference method, repeatability, the carry-over between samples, the temperature compensation and the behaviour of the instrument at the ends of its measuring range.

It applies to analysers based on the vertical sedimentation test. Issued on 17 June 2014, it has applied since 1 July 2015.

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Document preview — YY/T 1251-2014

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 erythrocyte sedimentation rate measurement instrument requirements, test methods, labels, signs and instructions for use, packaging, transport and storage.

This standard applies to vertical sedimentation test erythrocyte sedimentation rate erythrocyte sedimentation rate measurement instrument (hereinafter referred to as the analyzer).

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 safety requirements for electrical equipment - Part 1. General requirements

GB/T 14710 medical electrical environmental requirements and test methods Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General Claim

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 Appearance

Appearance should meet the following requirements.

a) clean and tidy appearance of the instrument;

b) nameplate and labels should be clear.

3.2 Compliance rate

And Westergren method that conformity rate should be not less than 90.0%.

3.3 Detection Repeatability

Shall meet the following requirements.

a) 0 ~ 10mm/h sample test results obtained standard deviation (SD) should be less than 1.5mm/h;

b) greater than 10mm/h sample test results obtained in the coefficient of variation (CV) should not exceed 15%.

3.4 Channel Consistency

3.4.1 10 holes (or more) Tester Shall meet the following requirements.

a) 0 ~ 10mm/h of fresh blood sample test results obtained standard deviation (SD) should be less than 1.5mm/h;

b) greater than 10mm/h Fresh blood testing resulting coefficient of variation (CV) should not exceed 15%.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

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