YY/T 0996-2015Urine formed element analyzer(digital imaging automatic identification) (English PDF)
尿液有形成分分析仪（数字成像自动识别）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 0996-2015 is the English-translated version of 尿液有形成分分析仪（数字成像自动识别）.
YY/T 0996-2015 is the Chinese pharmaceutical industry standard for the urine formed element analyzer that identifies the elements automatically from a digital image.
It specifies the terms and definitions, the requirements, the test methods, the marking, the labelling, the instruction manual and the rules for packaging, transport and storage, covering the accuracy and repeatability of the counts, the carry-over, the identification of the classes of element and its agreement with microscopy, the sample throughput and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 0996-2015
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
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)
The use of digital imaging technology for urine samples formed component analysis and automatic identification equipment.
3.2 Urinary formed elements
All tangible substances collectively urine samples under a microscope visible, including cells, casts, crystals microorganisms and parasites.
3.3 Urine
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 18268.1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
- GB/T 18268.26Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 26: Particular requirements -- In vitro diagnostic (IVD) medical equipment
- YY 0648Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 18268.1-2025 — Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
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YY/T 0996-2015
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