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YY/T 1456-2016: Human ferritin quantitative test reagent
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1456-2016 | English | 159 |
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Human ferritin quantitative test reagent
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YY/T 1456-2016
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PDF similar to YY/T 1456-2016
Basic data | Standard ID | YY/T 1456-2016 (YY/T1456-2016) | | Description (Translated English) | Human ferritin quantitative test reagent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,872 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1456-2016: Human ferritin quantitative test reagent---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.
Human ferritin quantitative test reagent
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Ferritin quantitative detection reagent (box)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Zhengzhou Antu Biological Engineering Co., Ltd., Beijing Yuande Biomedical
Limited, Beckman Coulter Trading (China) Limited.
The main drafters of this standard. Wang Ruixia, Lu Qingyue, Tang Lei, Zhang Hong
Ferritin quantitative detection reagent (box)
1 Scope
This standard specifies the requirements, test methods and signs, labels, instructions for use, packaging, shipping and labeling of ferritin quantitative reagents (cartons)
Storage and other content.
This standard applies to the antigen-antibody reaction as the basic principle of quantitative detection of blood samples or urine samples of ferritin in the reagent (box)
(Hereinafter referred to as "Ferr-reagent"), the kit method includes quantitative labeling immunization methods [such as enzyme-linked immunosorbent assay (ELISA), time
Resolution immunoassay, (electrochemiluminescence, etc.) and immunoturbidimetric methods (such as immunoturbidimetric turbidimetric method, latex enhanced immunoturbidimetric method, etc.).
This standard does not apply to the evaluation of ferritin calibrators and quality control products.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance
The origin of traceability
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should be based on the characteristics of the product packaging to specify the appropriate appearance requirements. Generally should be the composition of the components of the kit, traits, inner and outer packaging, labels
And so on.
a) kit components should be complete, both inside and outside the packaging should be complete, clear label;
b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation).
3.2 traceability
Should be based on GB/T 21415-2008 and the relevant provisions of the use of Ferr calibrators used in the source, the assignment process and measurement uncertainty
And so on.
3.3 Accuracy
Accuracy should meet one of the following requirements.
a) Relative deviation.
With a reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample,
The relative deviation of the measurement results should not exceed ± 10%.
b) Comparison test.
Ferr-reagent (box) with the specified analysis system for comparison test.
1) The correlation coefficient (r) should be not less than 0.950 and the slope should be within [0.9,1.1].
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