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Dry hematology analyzer (centrifuge method)
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Basic data
| Standard ID | YY/T 1452-2016 (YY/T1452-2016) |
| Description (Translated English) | Dry hematology analyzer (centrifuge method) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,841 |
| Date of Issue | 2016-01-26 |
| Date of Implementation | 2017-01-01 |
| Quoted Standard | GB/T 191; GB 4793.1; GB 4793.7; GB/T 14710; GB/T 18268.1; GB/T 18268.26; YY 0648; YY/T 0657 |
| Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the terms and definitions, composition, requirements, test methods, signs, labels, instructions, packaging, shipping and storage of dry blood cell analyzers (centrifugation). This standard is applicable to dry blood cell analyzer (centrifugation) (hereinafter referred to as analyzer) for quantitative analysis of cellular components in human blood. |
YY/T 1452-2016: Dry hematology analyzer (centrifuge method)
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Dry hematology analyzer (centrifuge method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Dry blood cell analyzer
(Centrifugation)
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 the standard units. Beijing Medical Devices Testing Institute, Beijing times Ken Sunny Technology Development Co., Ltd.
The main drafters of this standard. continued Yong, Liu Guangzhong.
Introduction
The dry blood cell analyzer is a blood cell component that is mounted in a capillary tube containing a fluorescent reagent and a float by centrifugation
Layered, and its cell components for quantitative analysis of the instrument.
This type of instrument is suitable for routine routine examination of blood cells and is not suitable for the diagnosis of blood system diseases. Such instruments are unclear
Other methods should be tested.
Dry blood cell analyzer
(Centrifugation)
1 Scope
This standard specifies the terms and definitions, composition, requirements, test methods, signs, labels, and use of a dry blood cell analyzer (centrifugation)
Brochures, packaging, transportation and storage.
This standard is applicable to dry blood cell analyzer (centrifugal method) for quantitative analysis of cellular components in human blood (hereinafter referred to as sub-
Instrument).
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 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.7 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 7. Particular requirements for laboratory centrifuges
Environmental requirements and test methods for medical appliances GB/T
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 26. Particular requirements
Diagnostic (IVD) medical equipment
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
Of the special requirements
YY/T 0657 Medical centrifuge
3 terms and definitions
The following terms and definitions apply to this document.
3.1
The blood cell components contained in the capillary tube containing the fluorescent reagent and the float were stratified by centrifugation and the cell composition
Quantitative analysis of the instrument.
4 composition
The analyzer consists of a dedicated desktop high-speed centrifuge and a reader.
...
