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YY/T 0996-2015 English PDF

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YY/T 0996-2015: Urine formed element analyzer(digital imaging automatic identification)
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Basic data

Standard ID YY/T 0996-2015 (YY/T0996-2015)
Description (Translated English) Urine formed element analyzer(digital imaging automatic identification)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.1
Word Count Estimation 9,952
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; GB/T 18268.1; GB/T 18268.26; YY/T 0466.1; YY 0648
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard specifies the urine visible component analyzer (Digital Imaging Automatic Identification) terms and definitions, requirements, test methods, marking, labeling and instructions, packaging, transport and storage. This Standard applies to the physical components of urine analyzers based on automatic digital imaging and automatic recognition principle.

YY/T 0996-2015: Urine formed element analyzer(digital imaging automatic identification)

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Urine formed element analyzer (digital imaging automatic identification) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Urinary formed elements analyzer (Digital Imaging Automatic Identification) Issued on. 2015-03-02 2016-01-01 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. People's Liberation Army General Hospital, Beijing Medical Device Testing, Ai Weike Technology Co., Ltd., Guilin gifted Litvin Medical Electronics Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Changchun Dheere Medical Technology Co., Ltd., Hangzhou Long Xin Technology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Hunan Province, medical equipment and pharmaceutical packaging materials (container) detection. The main drafters of this standard. Ma Junlong, Yang Zongbing, Zhoufeng Liang, Jiang Jun, He Yanfeng, often Shuqin, Liu Guanghua, Tian Wei, Jin Teng Chen-chung.

Introduction

Urine formed component analysis, each sample should be carried out on the principle of microscopic examination, but based on a large amount of practical work sample inspection report To send a timely and other reasons, can not one by one each specimen for microscopic examination visible components. They can do this by means of screening solve mirror Inspection work, "supply and demand." At present, the commonly used screening methods are mainly for the chemical composition of urine "dry chemistry", targeted urine Forming a minute, "Digital Imaging Automatic Identification Law" and "flow cytometry." Results of "Digital Imaging Automatic Identification Law" and "flow cytometry" two types of automatic analysis instrument in the clinical urine samples only have formed Screening points, after the screening of samples for further confirmation of the order shall report after manual identification. Urinary formed elements analyzer (Digital Imaging Automatic Identification)

1 Scope

This standard specifies the urine formed component analyzer (Digital Imaging Automatic Identification) terms and definitions, requirements, test methods, marking, labeling And brochures, packaging, transport and storage. This standard applies to the urine formed elements analyzer (hereinafter referred to as the analyzer) automatically based on digital imaging and automatic recognition principle.

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 GB/T 18268.1 measurement, control and laboratory use EMC requirements for electrical equipment Part 1. General requirements GB/T 18268.26 measurement, control and laboratory use EMC requirements for electrical equipment Part 26. Particular requirements for body External diagnostic (IVD) medical equipment Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Urinary formed elements analyzer (Digital Imaging Automatic Identification) urineformedelementanalyzer (digitalimagingautomatic identification) The use of digital imaging technology for urine samples formed component analysis and automatic identification equipment. 3.2 Urinary formed elements urineformedelement All tangible substances collectively urine samples under a microscope visible, including cells, casts, crystals microorganisms and parasites. 3.3 Urine urinesediment Natural subsidence or urine sample after centrifugation, the observed visible components under a microscope.

4 Requirements

4.1 Appearance The skin should meet the following requirements.

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