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YY/T 1251-2014 English PDF

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YY/T 1251-2014: Erythrocyte sedimentation rate analyzer
Status: Valid
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YY/T 1251-2014English209 Add to Cart 3 days [Need to translate] Erythrocyte sedimentation rate analyzer Valid YY/T 1251-2014

PDF similar to YY/T 1251-2014


Standard similar to YY/T 1251-2014

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Basic data

Standard ID YY/T 1251-2014 (YY/T1251-2014)
Description (Translated English) Erythrocyte sedimentation rate analyzer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 9,931
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; YY/T 0466.1-2009; 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 vertical sedimentation test erythrocyte sedimentation rate of the erythrocyte sedimentation rate measurement instrument. This Standard specifies the erythrocyte sedimentation rate measurement instrument requirements, test methods,

YY/T 1251-2014: Erythrocyte sedimentation rate 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.
Erythrocyte sedimentation rate analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Erythrocyte sedimentation rate measurement instrument 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. PLA General Hospital, Beijing Medical Device Testing, Beijing Science and Technology Development Co., Ltd. Saikexide. The main drafters of this standard. Deng Xinli, continued Yong, Ding Hui heavy. Erythrocyte sedimentation rate measurement instrument

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%.

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