YY/T 1155-2019_English: PDF (YY/T1155-2019)
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Automatic luminescence immunoassay analyzer
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Automatic Luminescence Immunoassay Analyzer
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| Standard ID | 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 | 14,185 | | Date of Issue | 2019 | | Date of Implementation | 2020-06-01 | | Summary | This standard specifies the requirements, test methods, labeling, marking and instructions for use, packaging, transportation and storage of fully automatic luminescence immunoassay analyzers. This standard applies to automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. The analyzer adopts luminescence system and immunoassay method to quantitatively or qualitatively detect various analytes in human serum, plasma or other body fluids, including luminescence immunoassay analyzers based on the principles of chemiluminescence, electrochemiluminescence, and fluorescence. This standard does not apply to: luminescence immunoassay analyzer based on image recognition; automatic luminescence immunoassay analyzer for point-of-care testing (POCT). | | Standard ID | YY/T 1155-2009 (YY/T1155-2009) | | 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 | 8,869 | | Date of Issue | 2009-12-30 | | Date of Implementation | 2011-06-01 | | Quoted Standard | GB/T 191; GB/T 14710; GB 4793.1-2007; YY 0466-2003 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | | Regulation (derived from) | China Food & Drug Administration Announcement 2009 No.83 | | Summary | This standard specifies the fully automated immunoassay analyzer requirements, test methods, marking, labeling and brochures, packaging, transport and storage of materials. This standard applies to automated immunoassay analyzer (hereinafter referred to as the analyzer). Analyzer using luminescence immunoassay systems and methods of human serum, plasma or other body fluids of various analytes quantitative and qualitative detection, including those based on chemiluminescence, electrochemiluminescence, such as the principle of fluorescence immunoassay analyzer. |
YY/T 1155-2019
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
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
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 1: General requirements
GB/T 18268.26 Electrical equipment for measurement, control and laboratory use
- EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD)
medical equipment
GB/T 29791.3 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional
use
YY 0648 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical 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.
3.2 luminescence immunoassay analyzer
Immunoassay analyzers that are based on luminescent immunoassay technology and
can perform qualitative or quantitative testing.
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.
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. If there are no national standards or industry standards, it shall comply with
the manufacturer's specifications.
4.6 Main functions of the analyzer
The analyzer shall have the following main functions:
a) Users can use human-computer dialogue instructions to enable the instrument
to automatically complete the analysis tasks of different samples and test items;
b) The instrument shall be able to indicate the status of consumables such as
reagents and waste;
c) The instrument has a self-checking function;
d) Fault prompts: The instrument shall have corresponding prompts for operating
errors, and mechanical and circuit failures.
4.7 Appearance
The appearance of the analyzer shall meet the following requirements:
a) The appearance shall be neat, without cracks or scratches, and the text and
logos shall be clear;
b) The moving parts of the analysis system shall be stable and shall not get stuck
or jump;
c) Fastener connections shall be firm and reliable without any looseness.
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.
4.10 Electromagnetic compatibility requirements
It shall comply with the applicable provisions of GB/T 18268.1 and GB/T 18268.26.
5 Test methods
5.1 Normal working environment conditions
5.1.1 Power supply voltage: 220 V±22 V; 50 Hz±1 Hz;
5.1.2 Ambient temperature: 10 ℃~30 ℃;
5.1.3 Relative humidity: 30%~70%;
5.1.4 Atmospheric pressure: 85.0 kPa~106.0 kPa;
5.1.5 Stay away from strong electromagnetic interference;
5.1.6 Avoid direct exposure to strong light;
5.1.7 There is a good grounding environment.
NOTE: When the conditions in 5.1.2~5.1.4 are inconsistent with the manufacturer's specifications, the
manufacturer's specifications shall prevail. The manufacturer shall specify them in the product technical
requirements.
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:
a) Place the analyzer, degassed pure water, etc. in a constant temperature and
humidity laboratory for several hours before starting the test. Prepare a suitable
container (to prevent the water in the container from evaporating) and adjust
the zero value on an electronic balance with a graduation value of 0.01 mg;
b) Place the container in a suitable position, control the reagent needle or sample
needle to add a specified amount of degassed pure water into the container,
and then weigh its mass on the electronic balance;
c) Repeat the measurement 20 times for each specified addition amount. The
actual addition amount each time is equal to the mass of the degassed pure
water added divided by the density of pure water at the current temperature.
The density of pure water at different temperatures can be found in Appendix
A. Calculate the actual value vi of each addition and calculate the average value
̅;
The test can be carried out by the luminescent agent method or the reference light source
method. Use the analyzer and the reference light source or luminescent agent at two
levels, high and low, within the linear range to test. Test 10 times in a row and record
the luminescence values. Calculate the standard deviation and coefficient of variation
of the luminescence values. The coefficient of variation shall comply with the
provisions of 4.3.3.
5.4.4 Stability of luminescence value
The test can be carried out by the luminescent agent method or the reference light source
method. After the analyzer is turned on and in a stable working state, use the reference
light source or luminescent agent at two levels, high and low, within the linear range to
test; repeat the test three times, record the luminescence values, and calculate the
average value I0 of the measurement results. After 4 hours and 8 hours, repeat the test
three times on the machine respectively, and calculate the average values I1 and I2 of
the measurement results; take I0 as the reference value, and calculate the relative bias
(α) according to formula (6), which shall meet the requirements of 4.3.4.
where:
α -- the relative bias of luminescence values;
Ii -- the measured values at 4 h and 8 h;
I0 -- initial measurement value.
5.5 Carryover
The test is carried out as follows:
a) The manufacturer specifies the clinical test item;
b) Prepare a high-concentration sample (Iprimary) for the clinical test item; the
concentration of the high-concentration sample shall be at least 105 times the
detection limit of the detection system;
NOTE: If the detection system cannot accurately detect high-concentration samples due to
limitations in the measurement range of the analyzer or reagents, the dilution extrapolation
method can be used.
c) Use the reagents for the clinical test item specified by the manufacturer, take
high-concentration samples and zero-concentration samples as samples, and
test them on the analyzer in the order of high-concentration sample, high-
concentration sample, high-concentration sample, zero-concentration sample,
zero-concentration sample, and zero-concentration sample as a group; carry
out a total of 5 groups of such tests;
d) In each group of tests, the test value of the 4th sample is I4, and the test value
of the 6th sample is I6;
e) Calculate the carryover K of each group according to formula (7);
f) The carryover of the five groups shall all comply with the provisions of 4.4.
For analyzers that can only perform qualitative testing, it is not necessary to
calculate K, and I4, I5, and I6 are required to comply with the provisions of 4.4.
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.
5.11 Electromagnetic compatibility
The test is carried out according to the methods specified in GB/T 18268.1 and GB/T
18268.26. The results shall comply with the requirements of 4.10.
Iprimary
......
YY/T 1155-2009
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Automatic Luminescence Immunoassay
Analyzer
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 10
7 Packaging, transportation and storage ... 11
Foreword
The Standard was proposed by China Food and Drug Administration.
The Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organization of this Standard. Beijing Institute of Medical Device Testing, Abbott
Laboratories Ltd, Johnson & Johnson Medical (China) Ltd, Roche Diagnostics (Shanghai)
Limited, and Beckman Coulter Commercial Enterprise (China) Co., Ltd.
The main drafters of this Standard. Wang Jun, Wang Xuefeng, Zhang Zhang, Cai
Xiaorong, Zhang Jinwen, and Zhang Xinmei.
Automatic Luminescence Immunoassay Analyzer
1 Scope
This Standard specifies the requirements, test methods, marks, labels and instructions,
packaging, transportation, and storage of automatic luminescence immunoassay
analyzer.
This Standard applies to automatic luminescence immunoassay analyzer (hereinafter
referred to as “the Analyzer”). The Analyzer uses luminescent system and immunological
analyzing method to set and qualitatively detect human blood serum, plasma or other
body fluids in a variety of analytes, including luminescent immunoassay analyzers based
on principle of chemiluminescence, electrochemical luminescence, fluorescence, etc.
2 Normative references
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications
(excluding corrections) or revisions made thereafter shall not be applicable to this
Standard. For the undated documents so quoted, the latest editions shall be applicable to
this Standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
GB 4793.1-2007 Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1. General requirements (IEC 61010-1. 2001, IDT)
YY 0466-2003 Medical devices - Symbols to be used with medical device labels
labelling and information to be supplied (ISO 15223. 2000, IDT)
3 Terms and definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1
Luminescence immunoassay
It refers to the method to detect antigen or antibody, by combining luminescent system
The Analyzer shall be equipped with the following main functions.
a) Through the man-machine interactive instructions, users can make the instrument to
automatically complete the analytical tasks of different samples and test items;
b) The instrument shall be able to present the state of consumables and wastes such
as reagents;
c) The instrument is equipped with a self-checking function;
d) Fault prompt. The instrument shall have corresponding prompts for the operation
mistake, mechanical and electrical faults.
4.7 Appearance
The appearance shall meet the following requirements.
a) The appearance shall be clean and free of cracks or scratches, with clear words and
marks;
b) The moving parts of analysis system shall be smooth and shall not be stuck or
jumped;
c) Fasteners shall be connected firmly and reliably. It must not be loosen.
4.8 Safety requirements
It shall comply with the requirements of GB 4793.1-2007.
4.9 Requirements of environmental test
The environmental test shall meet the following requirements.
a) The climatic environment test shall comply with the provisions of Group I for climatic
environment test in GB/T 14710;
b) The mechanical environment test shall comply with the provisions of Group I for
mechanical environment test in GB/T 14710.
5 Test methods
5.1 Normal working environment conditions
5.1.1 Power supply voltage. 220 V ± 22 V, 50 Hz ± 1 Hz;
5.1.2 Environment temperature. 10°C-30°C;
5.1.3 Relative humidity. ≤70%;
5.11 Requirements of environmental test
The test shall be conducted in accordance with the method specified in GB/T 14710.
6 Marks, labels and instructions
The symbols used in the labels, marks and instructions of the Analyzer shall comply with
the requirements of YY 0466-2003.
6.1 Marks and labels
6.1.1 Outer marks
Outer marks, including the nameplate, of the instrument shall mark.
a) Name, model / trademark of the product;
b) Power supply conditions.
c) Ex-factory serial number and date;
d) Name of manufacturing enterprise.
6.1.2 Outer packaging
The external packaging of the instrument shall mark.
a) Name, model / trademark of the product;
b) Size and weight;
c) Ex-factory serial number or date;
d) Transportation and storage marks. Graphic marks shall comply with provisions of
GB/T 191;
e) The allowable environmental conditions for transportation and storage;
f) Name and address of manufacturing enterprise.
6.2 Instructions
The instructions, including operating instructions and technical specifications, shall
comply with relevant requirements of GB 4793.1-2007 for the instructions.
7 Packaging, transportation and storage
7.1 Packaging
Product packaging shall comply with the following requirements.
a) Accessories and accompanying documents shall be accompanied with the product
and placed in the corresponding independent package;
b) The external packing box shall be able to ensure that products are free of
mechanical and natural damages;
c) The accompanying documents shall include the product specifications and packing
list;
d) The outer of packing box shall mark the marks specified by GB/T 191.
7.2 Transportation
Transportation shall be in accordance with the requirements specified in the Order
Contract.
7.3 Storage
Packaged analyzer shall be stored at the environment at -40°C-55°C, relative humidity not
more than 70%, without corrosive gases, and with ventilated conditions (when storage
conditions are not consistent with manufacturing enterprise’s nominal values, product’s
nominal values shall prevail. Manufacturing enterprise shall specify in the product
standard).
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