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YY/T 1155-2019

Chinese Standard: 'YY/T 1155-2019'
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YY/T 1155-2019English289 Add to Cart Days<=3 Automatic luminescence immunoassay analyzer Valid YY/T 1155-2019
YY/T 1155-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

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Detail Information of YY/T 1155-2019; YY/T1155-2019
Description (Translated English): Automatic luminescence immunoassay analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 14,135
Date of Issue: 2019-05-31
Date of Implementation: 2020-06-01
Drafting Organization: Beijing Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen New Industry Biomedical Engineering Co., Ltd., Antu Experimental Instrument (Zhengzhou) Co., Ltd., Beijing Kemei Biotechnology Co., Ltd., Changchun Dirui Medical Technology Co., Ltd. Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Beckman Coulter Trading (China) Co., Ltd.
Administrative Organization: National Medical Clinical Laboratory and In vitro Diagnostic System Standardization Technical Committee (SAC/TC 136)
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration

YY/T 1155-2019
Automatic luminescence immunoassay analyzer
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1155-2009
Fully automatic illuminating immunoassay analyzer
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard replaces YY/T 1155-2009 "Full-automatic Luminous Immunoassay Analyzer", compared with YY/T 1155-2009, except for editorial repair
The main technical changes changed are as follows.
--- Added "This standard does not apply to illuminating immunoassays based on image recognition" (see Chapter 1);
--- Added electromagnetic compatibility standards, special standards for in vitro diagnostic equipment safety, and in vitro diagnostic equipment labeling standards. The specific adjustments are as follows.
● Added references to GB 4793.6, GB 4793.9 and YY 0648 (see 5.10);
● Added references to GB/T 18268.1 and GB/T 18268.26 (see 5.11);
● Added reference to GB/T 29791.3 (see 6);
● YY 0466 has been deleted (see 6 of the.2009 edition).
--- In the list of normative references, the year number of the listed standard is deleted (see Chapter 2);
--- Increased the accuracy and repeatability of the sample and the corresponding test methods (see 4.1 and 5.2);
--- Revised the requirements for the correctness and volatility of the temperature control of the reaction zone and the corresponding test methods (see 4.2 and 5.3,.2009 edition)
4.1 and 5.3);
--- Increased the requirements of the light detection device section and the corresponding test methods (see 4.3 and 5.4);
--- Removed analyzer stability and increased luminescence stability (see 4.3.4 and 5.4.4,.2009 editions 4.2 and 5.4);
--- Removed linear correlation and increased linearity of luminescence values (see 4.3.2 and 5.4.2, 4.4 and 5.6 for.2009);
--- Increased the requirements for carrying contamination of analyzers that can only report qualitative test results (see 4.4);
--- Revised the intra-assay precision requirements of the clinical project and the corresponding test methods (see 4.5 and 5.6);
--- Added GB 4793.6, GB 4793.9, YY 0648 safety requirements and test methods (see 4.9 and 5.10);
--- Added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility requirements and test methods (see 4.10 and 5.11);
--- Labels, markings and instructions for use should be in accordance with the requirements of GB/T 29791.3 (see 6);
--- Added Appendix A Pure Water Density Table (see Appendix A).
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen New Industrial Students
Medical Engineering Co., Ltd., Antu Experimental Instrument (Zhengzhou) Co., Ltd., Beijing Kemei Biotechnology Co., Ltd., Changchun Dirui Medical
Technology Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trade (Shanghai)
Ltd., Beckman Coulter Trading (China) Co., Ltd.
The main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei, Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Yan Yulan.
The previous versions of the standards replaced by this standard are.
---YY/T 1155-2009.
Fully automatic illuminating immunoassay analyzer
1 Scope
This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and
Storage.
This standard applies to the fully automatic illuminating immunoassay analyzer (hereinafter referred to as the analyzer) used in medical laboratories. Analyzer using illumination system
And immunoassay methods for quantitative or qualitative detection of various analytes in human serum, plasma or other body fluids, including chemical-based
A light-emitting immunoassay analyzer based on the principles of light, electrochemiluminescence, and fluorescence.
This standard does not apply to. light-emitting immunoassay analyzer based on image recognition; full-automatic illumination immunoassay analyzer for immediate inspection (POCT).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory - Part 26. Particular requirements
External diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 3. Professional in vitro diagnostic equipment
Safety of electrical equipment for measurement, control and laboratory use - 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
Luminescence immunoassay luminescenceimmunoassay
A method of combining an illuminating system with an immune response to detect an antigen or antibody.
3.2
Luminescence immunoassay analyzer luminescenceimmunoassayanalyzer
An immunoassay analyzer based on luminescent immunoassay technology can perform qualitative or quantitative detection.
3.3
All analytical procedures include the addition of samples and reagents, the provision of immunological binding reactions, data measurements, calculation of results, and output.
YY/T 1155-2019
Automatic luminescence immunoassay analyzer
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1155-2009
Fully automatic illuminating immunoassay analyzer
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard replaces YY/T 1155-2009 "Full-automatic Luminous Immunoassay Analyzer", compared with YY/T 1155-2009, except for editorial repair
The main technical changes changed are as follows.
--- Added "This standard does not apply to illuminating immunoassays based on image recognition" (see Chapter 1);
--- Added electromagnetic compatibility standards, special standards for in vitro diagnostic equipment safety, and in vitro diagnostic equipment labeling standards. The specific adjustments are as follows.
● Added references to GB 4793.6, GB 4793.9 and YY 0648 (see 5.10);
● Added references to GB/T 18268.1 and GB/T 18268.26 (see 5.11);
● Added reference to GB/T 29791.3 (see 6);
● YY 0466 has been deleted (see 6 of the.2009 edition).
--- In the list of normative references, the year number of the listed standard is deleted (see Chapter 2);
--- Increased the accuracy and repeatability of the sample and the corresponding test methods (see 4.1 and 5.2);
--- Revised the requirements for the correctness and volatility of the temperature control of the reaction zone and the corresponding test methods (see 4.2 and 5.3,.2009 edition)
4.1 and 5.3);
--- Increased the requirements of the light detection device section and the corresponding test methods (see 4.3 and 5.4);
--- Removed analyzer stability and increased luminescence stability (see 4.3.4 and 5.4.4,.2009 editions 4.2 and 5.4);
--- Removed linear correlation and increased linearity of luminescence values (see 4.3.2 and 5.4.2, 4.4 and 5.6 for.2009);
--- Increased the requirements for carrying contamination of analyzers that can only report qualitative test results (see 4.4);
--- Revised the intra-assay precision requirements of the clinical project and the corresponding test methods (see 4.5 and 5.6);
--- Added GB 4793.6, GB 4793.9, YY 0648 safety requirements and test methods (see 4.9 and 5.10);
--- Added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility requirements and test methods (see 4.10 and 5.11);
--- Labels, markings and instructions for use should be in accordance with the requirements of GB/T 29791.3 (see 6);
--- Added Appendix A Pure Water Density Table (see Appendix A).
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen New Industrial Students
Medical Engineering Co., Ltd., Antu Experimental Instrument (Zhengzhou) Co., Ltd., Beijing Kemei Biotechnology Co., Ltd., Changchun Dirui Medical
Technology Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trade (Shanghai)
Ltd., Beckman Coulter Trading (China) Co., Ltd.
The main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei, Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Yan Yulan.
The previous versions of the standards replaced by this standard are.
---YY/T 1155-2009.
Fully automatic illuminating immunoassay analyzer
1 Scope
This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and
Storage.
This standard applies to the fully automatic illuminating immunoassay analyzer (hereinafter referred to as the analyzer) used in medical laboratories. Analyzer using illumination system
And immunoassay methods for quantitative or qualitative detection of various analytes in human serum, plasma or other body fluids, including chemical-based
A light-emitting immunoassay analyzer based on the principles of light, electrochemiluminescence, and fluorescence.
This standard does not apply to. light-emitting immunoassay analyzer based on image recognition; full-automatic illumination immunoassay analyzer for immediate inspection (POCT).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory - Part 26. Particular requirements
External diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 3. Professional in vitro diagnostic equipment
Safety of electrical equipment for measurement, control and laboratory use - 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
Luminescence immunoassay luminescenceimmunoassay
A method of combining an illuminating system with an immune response to detect an antigen or antibody.
3.2
Luminescence immunoassay analyzer luminescenceimmunoassayanalyzer
An immunoassay analyzer based on luminescent immunoassay technology can perform qualitative or quantitative detection.
3.3
All analytical procedures include the addition of samples and reagents, the provision of immunological binding reactions, data measurements, calculation of results, and output.
Related standard:   YY/T 1213-2019  YY/T 1645-2019
   
 
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