YY/T 1155-2019 PDF English
US$245.00 · In stock · Download in 9 secondsYY/T 1155-2019: Automatic luminescence immunoassay analyzer Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 1155: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1155-2019 | English | 245 |
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Automatic luminescence immunoassay analyzer
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| YY/T 1155-2009 | English | 120 |
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Automatic Luminescence Immunoassay Analyzer
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YY/T 1155-2019: Automatic luminescence immunoassay analyzer---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1155-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 1155-2009
Automatic luminescence immunoassay analyzer
Issued on. MAY 31, 2019
Implemented on. JUNE 1, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 6
5 Test methods... 9
6 Labels, markings, and instructions for use... 15
7 Packaging, transportation, and storage... 15
Appendix A (Informative) Densities of pure water at different temperatures under
standard atmospheric pressure... 16
References... 17
Foreword
This standard was drafted according to 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 does not assume the responsibility for identifying these
patents.
This standard replaces YY/T 1155-2009 Automatic Luminescence Immunoassay
Analyzer. Compared with YY/T 1155-2009, the main technical changes except editorial
modifications are as follows.
-- The content "This standard does not apply to luminescent immunoassay
analyzers based on image recognition" is added (see Chapter 1);
-- Electromagnetic compatibility standards, special safety standards for in vitro
diagnostic equipment, and labeling standards for in vitro diagnostic equipment
are added. The specific adjustments are as follows.
References to GB 4793.6, GB 4793.9, and YY 0648 are added (see 5.10);
References to GB/T 18268.1 and GB/T 18268.26 are added (see 5.11);
The reference to GB/T 29791.3 is added (see Chapter 6);
YY 0466 is deleted (see Chapter 6 in the 2009 edition).
-- In the list of normative references, the year numbers of the listed standards are
deleted (see Chapter 2);
-- The requirements and corresponding test methods for the accuracy and
repeatability of sample addition are added (see 4.1 and 5.2);
-- The requirements and corresponding test methods for the accuracy and
fluctuation of temperature control in the reaction zone are modified (see 4.2 and
5.3; see 4.1 and 5.3 of the 2009 edition);
-- The requirements and the corresponding test methods for light detection devices
are added (see 4.3 and 5.4);
-- The stability of the analyzer is deleted and the stability of the luminescence value
is added (see 4.3.4 and 5.4.4; see 4.2 and 5.4 of the 2009 edition);
-- The linear correlation is deleted and the linearity of luminescence value is added
(see 4.3.2 and 5.4.2; see 4.4 and 5.6 of the 2009 edition);
-- The requirements for carryover of analyzers that can only report qualitative test
results are added (see 4.4);
-- The intra-batch precision requirements and corresponding test methods for
clinical items are modified (see 4.5 and 5.6);
-- The safety requirements and test methods specified in GB 4793.6, GB 4793.9,
YY 0648 are added (see 4.9 and 5.10);
-- Electromagnetic compatibility requirements and test methods specified in GB/T
18268.1 and GB/T 18268.26 are added (see 4.10 and 5.11);
-- Labels, markings, and instructions for use are modified they shall comply with
the requirements of GB/T 29791.3 (see Chapter 6);
-- Appendix A the pure water density table is added (see Appendix A).
This standard was proposed by the National Medical Products Administration.
This standard shall be under the jurisdiction of the National Technical Committee on
Clinical Laboratory Testing and Invitro Diagnostic Test Systems of Standardization
Administration of China (SAC/TC136).
Drafting organizations of this standard. Beijing Institute of Medical Device Test,
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen New Industry
Biomedical Engineering Co., Ltd., Autobio Labtec Instruments (Zhengzhou) Co., Ltd.,
Chemiclin Diagnostics Co., Ltd., Changchun Dirui Medical Technology Co., Ltd.,
Xiamen Innodx Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd.,
Abbott Laboratories Trading (Shanghai) Co., Ltd., Beckman Coulter Commercial
Enterprise (China) Co., Ltd.
Main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei,
Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Zang Yulan.
The previous versions of the standards replaced by this standard are as follows.
-- YY/T 1155-2009.
Automatic luminescence immunoassay analyzer
1 Scope
This standard specifies the requirements, test methods, labels, markings and
instructions for use, packaging, transportation, and storage of automatic luminescence
immunoassay analyzers.
This standard applies to automatic luminescence immunoassay analyzers (hereinafter
referred to as analyzers) used in medical laboratories. Analyzers use luminescent
systems and immunoassay methods to quantitatively or qualitatively detect various
analytes in human serum, plasma, or other body fluids, including luminescence
immunoassay analyzers based on chemiluminescence, electrochemiluminescence,
fluorescence, and other principles.
This standard does not apply to luminescence immunoassay analyzers based on image
recognition and automatic luminescence immunoassay analyzers for point-of-care
testing (POCT).
2 Normative references
The following documents are essential for the application of this document. For any
referenced document with a date, only the version with the date applies to this document.
For any referenced document without a date, the latest version (including all
amendments) applies to this document.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 4793.1 Safety requirements for electrical equipment for measurement, control,
and laboratory use - Part 1.General requirements
GB 4793.6 Safety requirements for electrical for measurement, control, and
laboratory use - Part 6.Particular requirements for laboratory equipment for the
heating of materials
GB 4793.9 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 9.Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other purposes
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 luminescence immunoassay
A method that combines a luminescent system with an immune response to detect
antigens or antibodies.
3.3 automatic luminescence immunoassay analyzer
A luminescence immunoassay analyzer by which all analytical processes including the
injection of samples and reagents, the provision of the immune binding reaction
environment, data measurement, result calculation and output are implemented
automatically.
4 Requirements
4.1 Accuracy and repeatability of sample addition
The minimum and maximum sample loading volumes and the minimum and maximum
reagent loading volumes specified on the instrument shall be tested and shall comply
with the requirements of Table 1.
4.3 Light detection device
4.3.1 Instrument noise
The manufacturer's specifications shall not be exceeded.
4.3.2 Linearity of luminescence values
In the range of no less than 3 luminescence value orders of magnitude, the linear
correlation coefficient (r) shall be ≥0.99.
4.3.3 Repeatability of luminescence values
4.3.4 Stability of luminescence values
4.4 Carryover
The carryover rate shall be ≤10-5.For analyzers that can only report qualitative test
results, negative samples cannot be tested as positive after high-concentration positive
samples are tested.
4.5 Intra-batch precision of clinical items
Select at least one clinical item and conduct the intra-batch precision test using the
calibrators and kits specified by the manufacturer. The intra-batch precision shall
comply with the requirements of the corresponding national standards and industry
standards.
4.6 Main functions of the analyzer
The analyzer shall have the following main functions.
4.7 Appearance
The appearance of the analyzer shall meet the following requirements.
4.8 Environmental test requirements
It shall meet the requirements of climate environment group I and mechanical
environment group I in GB/T 14710.
4.9 Security requirements
It shall comply with the requirements of applicable clauses in GB 4793.1, GB 4793.6,
GB 4793.9, and YY 0648.
5 Test methods
5.1 Normal working environment conditions
5.1.1 Power supply voltage. 220 V±22 V; 50 Hz±1 Hz;
5.2 Accuracy and repeatability of sample addition
There are two types of determination methods. colorimetry and weighing method.
Manufacturers can choose either method.
5.2.1 Weighing method
The weighing method is carried out according to the following steps.
5.2.2 Colorimetry
The colorimetric method is carried out according to the following steps.
5.3 Accuracy and fluctuation of temperature control in the reaction zone
Place the probe of a temperature detector with a resolution of not less than 0.1 °C, or a
calibrated special temperature measuring tool with the same accuracy provided by the
analyzer manufacturer, at the location specified by the manufacturer.
5.4 Light detection device
5.4.1 Instrument noise
After the analyzer is turned on and in a stable working state, use a blank sample to test
for 20 consecutive times, record the luminescence value of each test, calculate the
arithmetic mean 𝐼 ̅ of the luminescence values, and calculate the instrument noise IB
according to formula (5), which shall meet the requirements of 4.3.1.
5.4.2 Linearity of luminescence values
One of the following two methods can be chosen.
5.6 Intra-batch precision of clinical items
Using calibrators and kits for the clinical test item specified by the manufacturer, test
the intra-batch precision in accordance with the corresponding national standards,
industry standards, or test kit technical requirements, which shall comply with the
provisions of 4.5.
5.7 Main functions of the analyzer
The verification is performed according to the instructions; the functions shall meet the
requirements of 4.6.
5.8 Appearance
Visual inspection is carried out; the appearance shall comply with the requirements of
4.7.
5.9 Environmental test requirements
The test is carried out according to the method specified in GB/T 14710.The results
shall meet the requirements of 4.8.
5.10 Security requirements
The test is carried out according to the methods specified in GB 4793.1, GB 4793.6,
GB 4793.9, and YY 0648, and the results shall meet the requirements of 4.9.
6 Labels, markings, and instructions for use
They shall comply with the requirements of GB/T 29791.3.
7 Packaging, transportation, and storage
7.1 Packaging
The packaging of the analyzer shall comply with the following provisions.
7.2 Transportation
Transportation shall be carried out in accordance with the requirements specified by the
manufacturer.
7.3 Storage
Storage shall be carried out in accordance with the manufacturer's instructions.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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