YY/T 1452-2016 English PDFUS$159.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1452-2016: Dry hematology analyzer (centrifuge method) Status: Valid
Basic dataStandard 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: 8,892 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)---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.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 ForewordThis 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.IntroductionThe 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 ScopeThis 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 documentsThe 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 centrifuge3 terms and definitionsThe 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 compositionThe analyzer consists of a dedicated desktop high-speed centrifuge and a reader. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1452-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1452-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1452-2016_English with my colleagues?Answer: Yes. 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