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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard replaces YY/T 1155-2009 Automatic luminescence immunoassay analyzer. In addition to a number of editorial changes, the following technical changes have been made with respect to YY/T 1155-2009:
——"This standard is not applicable to image-recognition based luminescence immunoassay analyzers" has been added (see Clause 1);
——Electromagnetic compatibility standards, particular safety standard for in vitro diagnostic equipment and labeling standard for in vitro diagnostic equipment have been added, with the specific adjustments as follows:
GB 4793.6, GB 4793.9 and YY 0648 have been added for reference (see 5.10);
GB/T 18268.1 and GB/T 18268.26 have been added for reference (see 5.11);
GB/T 29791.3 has been added for reference (see 6);
YY 0466 has been deleted (see 6 in 2009 edition);
——In the list of normative references, the years of the listed standards has been deleted (see Clause 2);
——The requirements and corresponding test methods for sample addition accuracy and repeatability have been added (see 4.1 and 5.2);
——The requirements and corresponding test methods for the accuracy and fluctuation of temperature control in reaction zone have been modified (see 4.2 and 5.3; 4.1 and 5.3 in 2009 edition);
——The requirements and corresponding test methods for the requirements and test method for luminescence detection device part have been added (see 4.3 and 5.4).
——The analyzer stability has been deleted and the stability of luminescence value has been added (see 4.3.4 and 5.4.4; 4.2 and 5.4 in 2009 edition);
——The linear dependence has been deleted and the linearity of luminescence value has been added (see 4.3.2 and 5.4.2; 4.4 and 5.6 in 2009 edition);
——The requirements for carryover of the analyzer that only reports qualitative test results have been added (see 4.4);
——The requirements and corresponding test methods for the in-batch precision of clinical projects have been modified (see 4.5 and 5.6);
——The safety requirements and test methods in GB 4793.6, GB 4793.9 and YY 0648 have been added (see 4.9 and 5.10);
——The electromagnetic compatibility requirements and test methods in GB/T 18268.1 and GB/T 18268.26 have been added (see 4.10 and 5.11);
——The requirements for labeling, marking and instructions for use have been changed to "They shall meet the requirements of GB/T 29791.3" (see Clause 6);
——A table for the density of pure water has been added in Annex A (see Annex A);
This standard was proposed by the National Medical Products Administration.
This collateral standard is under the jurisdiction of SAC/TC 136 National Technical Committee on Medical Clinical Laboratory Testing and In vitro Diagnostic Test Systems Standardization Administration of China.
The previous edition of this standard is as follows:
——YY/T 1155-2009.
Automatic luminescence immunoassay analyzer
1 Scope
This standard specifies the requirements, test methods, labeling, marking, instructions for use, packaging, transportation and storage of the automatic luminescence immunoassay analyzer.
This standard is applicable to automatic luminescence immunoassay analyzers used in medical laboratories (hereinafter referred to as “analyzer”). The analyzer uses luminescence system and immunoassay method to quantitatively or qualitatively detect various analytes in human serum, plasma or other body fluids, and includes luminescence immunoassay analyzers based on principles, such as chemiluminescence, electrochemiluminescence and fluorescence.
This standard is not applicable to image-recognition based luminescence immunoassay analyzers and automatic luminescence immunoassay analyzer for point of care testing (POCT).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
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
For the purposes of this document, the following terms and definitions apply.
3.1
luminescence immunoassay
method of detecting antigens or antibodies by combining luminescence system with immune response
3.2
luminescence immunoassay analyzer
immune analyzer, based on luminescence immunoassay technology, may be used for qualitative or quantitative detection
3.3
automatic luminescence immunoassay analyzer
luminescence Immunoassay analyzer with automation in the whole analytical processes including addition of samples and reagents, provision of immunobinding reaction environment, data measurement, result calculation and output
4 Requirements
4.1 Sample addition accuracy and repeatability
The test of the nominal minimum and maximum sample addition and reagent addition on the instrument shall meet the requirements of Table 1.
Table 1 Requirements for sample addition accuracy and repeatability
Nominal sample addition (v)/μL Requirements
Bias Coefficient of variation (CV)/%
v ≤ 10 Not exceeding ± 1 μL ≤ 5
10 < v ≤ 50 Not exceeding ± 10% ≤ 3
v > 50 Not exceeding ± 5% ≤ 2
4.2 Accuracy and fluctuation of temperature control in reaction zone
The temperature bias in reaction zone shall be within ± 0.5°C of the set value, and the temperature fluctuation shall not exceed 0.5°C.
4.3 Luminescence detection device part
4.3.1 Instrument noise
The noise shall meet the requirements of the manufacturer.
4.3.2 Linearity of luminescence value
The linear correlation coefficient (r) shall be ≥ 0.99 within the order of magnitude of not less than 3 luminescence values.
4.3.3 Repeatability of luminescence value
4.3.3.1 The coefficient of variation (CV) shall not exceed 5% if the luminescent agent method is adopted.
4.3.3.2 The coefficient of variation (CV) shall not exceed 3% if the reference light source method is adopted.
4.3.4 Stability of luminescence value
4.3.4.1 The change of luminescence value shall not exceed ± 10% if the luminescent agent method is adopted.
4.3.4.2 The change of luminescence value shall not exceed ± 5% if the reference light source method is adopted.
4.4 Carryover
The carryover rate shall be ≤ 10-5. For the analyzer that only reports qualitative test results, the high concentration positive samples shall be detected before the negative samples, and the negative samples cannot be detected as positive.
4.5 In-batch precision of clinical projects
At least one clinical project shall be selected to carry out in-batch precision test with calibration item and kits specified by manufacturers. The in-batch precision shall meet the requirements of corresponding national standards and professional standards. It shall comply with the manufacturer's regulations if national standard or professional standard is not available.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test method
6 Labeling, marking and instructions for use
7 Packaging, transportation and storage
Annex A (Informative) The density of pure water at different temperatures under standard atmospheric pressure
Bibliography
