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Erythrocyte sedimentation rate analyzer
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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 | 9,990 |
| 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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