YY/T 0475-2011Dry chemistry urine analyzer (English PDF)
干化学尿液分析仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0475-2011 is the English-translated version of 干化学尿液分析仪.
YY/T 0475-2011 is the Chinese pharmaceutical industry standard for the dry chemistry urine analyzer, the instrument that reads reagent strips photometrically.
It specifies the terms and definitions, the requirements, the test methods, the marking, the labelling and the instructions and the rules for packaging, transport and storage, covering the agreement of the results with the assigned values of control materials, the repeatability, the carry-over, the throughput, the stability of the optics and the electrical safety. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 0475-2011
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 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.
1 Scope
This standard specifies the urine dry chemistry analyzer terms and definitions, requirements, test methods, marking, labeling and instructions, packaging, transport and Storage and so on.
This standard applies to urine analyzer based on dry chemistry urine analysis test strips for analysis (hereinafter referred to as the analyzer).
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 use 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 electrical equipment, electromagnetic compatibility requirements - Part 1. General requirements
GB/T 18268.26 measurement, control and laboratory electrical equipment, electromagnetic compatibility requirements of Part 26. Particular requirements for in vitro Diagnostic (IVD) medical equipment
YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements Symbol YY/T 0466.1 medical equipment used with medical device labels, labeling and information provided
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Welterweight level
Each level corresponds to a qualitative range of concentrations.
Note 1. usually expressed as a nominal value within the range of concentrations;
Note 2. Each manufacturer claims that the order may be different.
4 Requirements
4.1 Appearance
The skin should meet the following requirements.
a) Instrument appearance neat, clean, surface coating, no coating peeling, scratches and dirt;
b) nameplate and logo should be clear.
......
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 0475-2011
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