YY/T 0475-2011 English PDF

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YY/T 0475-2011: Dry chemistry urine analyzer
Status: Valid

YY/T 0475: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0475-2011	189	Add to Cart	3 days	Dry chemistry urine analyzer	Valid
YY/T 0475-2004	279	Add to Cart	3 days	General technical requirements for urine analyzer	Obsolete

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Basic data

Standard ID: YY/T 0475-2011 (YY/T0475-2011)
Description (Translated English): Dry chemistry urine analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,851
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Older Standard (superseded by this standard): YY/T 0475-2004
Quoted Standard: GB/T 191; GB 4793.1; GB/T 14710; GB/T 18268.1; GB/T 18268.26; YY 0648; YY/T 0466.1
Regulation (derived from): China Food & Drug Administration Announcement 2011 No.106; Industry Standard Filing Announcement 2013 No.6 (Total No.162)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the urine dry chemistry analyzer terminology and definitions, requirements, test methods, signs, labels and instructions, packaging, transport and storage and so on. This standard applies to dried urine chemistry analyzer based on urine analysis test strip analysis (hereinafter referred to as the analyzer).

YY/T 0475-2011: Dry chemistry urine analyzer

---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 chemistry urine analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Replacing YY/T 0475-2004 Dry chemical urine analyzer Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

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. Release mechanism of the present document does not assume responsibility for the identification of these patents. Instead of the standard YY/T 0475-2004, compared with the YY/T 0475-2004 standard, the main changes are as follows. --- Standard name "Urine Chemistry Analyzer General technical conditions" to "urine dry chemistry analyzer"; --- Delete part reference standard's number; --- Increased YY 0648-2008 electrical safety requirements; --- Delete repetitive tests using test strips to test relevant content (2004 Version 3.4); --- Remove stability tests using test strips to test relevant content (2004 Version 3.6); --- Increased supply voltage on the portable device using DC power requirements; --- Increasing the term "order of magnitude"; --- Added a "carryover" requirements. This standard was proposed by the State 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. Beijing Medical Device Testing, Changchun Dheere Medical Technology Co., Ltd., Roche Diagnostics (Shanghai) Ltd. Guilin gifted Litvin Medical Electronics Co., Ltd. Jiang Xi Tekang. The main drafters of this standard. Yangzong Bing, Gu Xiaofeng Cui Zhuo, Zhou Yongqing, Xiao Yan, Du Haiou. This standard replaces the YY/T 0475-2004. Dry chemical urine analyzer

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. ......

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