US$189.00 ยท In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0475-2011: Dry chemistry urine analyzer Status: Valid YY/T 0475: Evolution and historical versions
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 0475-2011 | English | 189 |
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3 days [Need to translate]
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Dry chemistry urine analyzer
| Valid |
YY/T 0475-2011
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YY/T 0475-2004 | English | 279 |
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3 days [Need to translate]
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General technical requirements for urine analyzer
| Obsolete |
YY/T 0475-2004
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PDF similar to YY/T 0475-2011
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| Word Count Estimation | 8,851 | Date of Issue | 2011-12-31 | Date of Implementation | 2013-06-01 | Older Standard (superseded by this standard) | YY/T 0475-2004 | Quoted Standard | GB/T 191; GB 4793.1; GB/T 14710; GB/T 18268.1; GB/T 18268.26; YY 0648; YY/T 0466.1 | Regulation (derived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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